REPUBLIC OF LITHUANIA

REPUBLIC OF LITHUANIA REPUBLIC OF LITHUANIA LAW ON PHARMACY 22 June 2006 No X-709 Vilnius (As last amended on 16 December 2008 No XI-59) CHAPTER I GENERAL PROVISIONS Article 1. Purpose of the Law 1. This Law shall regulate pharmaceutical and other activity related to medicinal, investigational medicinal products, veterinary pharmaceuticals, active and other medicinal substances as well as medical purpose products, veterinary pharmaceutical activity as well as state management and control of the activity. The paragraph shall be valid until 1 July 2009. Hereinafter the words “medical purpose product” shall be deleted in the entire text of the Law 2. This Law shall not regulate the activity related to precursors of narcotic and psychotropic substances, state management and control of the activity. 3. The provisions of this Law have been harmonized with the legal acts of the European Union specified in Annex to this Law. Article 2. Definitions 1. Biological medicinal product means medicinal product the active substance(

1. s)of which are either biological substance(
2. s)or biological preparations or a mixture of such biological substance(
3. s)and such biological preparation(s). 2. Community Code of Medicinal Products means the list of medicinal products which by the decision of the Commission is granted a marketing authorisation in all EU Member States. 3. Common name of the medicinal product (hereinafter – common name) means the international non-proprietary name recommended by the World Health Organisation or, if one does not exist, the usual common name. 4. Decentralised procedure means the procedure during which the Member States of the European Economic Area (hereinafter the EEA) cooperates in considering applications for granting marketing authorisation of a medicinal product based on an identical dossier when such an authorisation has not yet been granted in any EEA Member State. 5. Wholesale distribution of medicinal products means pharmaceutical activity consisting of acquisition, holding, supply or export of medicinal products, except for their supply to natural persons. 6. Extemporaneous medicinal product means any medicinal product manufactured in a pharmacy for an individual subject of care based on a recipe on order of a health care establishment (Magistral Formula) or a medicinal product manufactured in accordance with the prescriptions of a pharmacopoeia (Officinal Formula). 7. European pharmacopoeia means the pharmacopoeia drawn up according to the Convention on the Elaboration of a European Pharmacopoeia. 8. European Medicines Agency means the Agency established according to the Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. 9. Pharmacy practice means practice of a pharmacist and of a pharmacist’s assistant (pharmacy technician): 1) pharmacist’s practice means pharmaceutical activity carried out by a pharmacist; 2) practice of a pharmacist’s assistant (pharmacy technician) means pharmaceutical activity carried out by a pharmacist’s assistant (pharmacy technician). 10. Pharmaceutical product means any medicinal product, investigational medicinal product, active substance and excipient entered in the list of the European Commission which are used as starting materials in the manufacture of medicinal products, medical purpose product. The paragraph shall be valid until 1 July 2009. The version of paragraph 10 after 1 July 2009: 10. Pharmaceutical product means any medicinal product, investigational medicinal product, active substance and excipient entered in the list of the European Commission which are used as starting materials in the manufacture of medicinal products. 11. Pharmaceutical specialist means pharmacist, pharmacist’s assistant (pharmacy technician) or the person equated to them according to the procedure established by an institution authorised by the Government. 12. Pharmaceutical information means information about pharmaceutical, clinical, pharmacological peculiarities of a medicinal product announced and spread in any form and by any means, also the prices of medicinal products in trade catalogues and price lists (if they contain no statements about the peculiarities of medicinal products). 13. Pharmacy service means the pharmacist’s practice in the pharmacy covering the control, evaluation of prescriptions issued by a doctor, selection of non-prescription medicinal products, supply to the general public, health care professionals and pharmaceutical specialists of pharmaceutical information about medicinal products, as well as provision of consultation to them. 14. Pharmaceutical activity means health promotion activity carried out by legal and/or natural persons, covering the manufacture, import from third countries, quality control of medicinal products, investigational medicinal products, active substances and excipients entered in the list of the European Commission which are used as starting materials for the manufacture of medicinal products; wholesale distribution of medicinal products, active substances and excipients entered in the list of the European Commission which are used as starting materials for the manufacture of medicinal products; parallel import of medicinal products, sale (dispensing) to the ultimate consumer; provision of pharmaceutical information about medicinal products and pharmaceutical waste management, except for its disposal. 15. Pharmaceutical waste means medicinal products that are subject to disposal (medicinal products that are defective, past the expiry date, confiscated, collected from the general public or counterfeit or waste materials from investigational medicinal products) and chemical materials used for the conduct of trials of medicinal products or defective chemical materials past the expiry date which were acquired for the purpose of conducting such trials. 16. Pharmacovigilance means a system of establishing, evaluating, reporting adverse reactions connected with the medicinal product and of preventing such risks. 17. Generic medicinal product means a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. 18. Homeopathic medicinal product (hereinafter referred to as homeopathic product) shall mean any medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain more than one component. 19. Immunological medicinal product (hereinafter referred to as immunological product) means medicinal product used to produce active or passive immunity or to diagnose the state of immunity, egg.: vaccine, toxin and serum, or any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an elegizing agent, egg. any allergen product. 20. Information about medicinal products means public information that may be provided as pharmaceutical information or as advertisement of medicinal products. 21. Outer packaging means the packaging into which is placed the immediate packaging. 22. Clinical trial of a medicinal product means any biomedical investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(
4. s)and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal products with the object of ascertaining its/their safety and/or efficacy. 23. Reimbursable medicinal products means medicinal products which are entered in the Price List of Reimbursable Medicinal Products and whose purchasing expenses or their part are subject to reimbursement from the budgetary resources of the Compulsory Health Insurance Fund for persons insured by compulsory health insurance. 24. Medicinal product derived from human blood and plasma means medicinal product industrially prepared by legal persons having such right. 25. Republic of Lithuania Register of Medicinal Products means the totality of legal, organisational, technological measures intended for granting medicinal products marketing authorisation and processing the marketing authorisation data. Entered in the Register shall be medicinal products for which marketing authorisation or marketing authorisation certificate has been issued. 26. Medical purposes product means a foodstuff having a pharmaceutical form, containing biologically active substances which condition its effect on the physiological functions of the human organism established by clinical trials and/or reasonable scientific literature and which is intended for strengthening the organism, its systems or organs and for maintaining their functioning. Repealed on 1 July 2009 27. Benefit and risk ratio means the ratio of beneficial therapeutic effect and danger posed to personal and public health established when assessing the quality, safety and effectiveness of the product . 28. Adverse reaction means a response to a medicinal product which is noxious and unintended and which occurs at doses of registered medicinal product normally used in a man intended for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function or any dose of the investigational medicinal product. 29. Adverse event means any untoward occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. 30. Unexpected adverse reaction means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics (e.g. summary of product characteristics for an authorised product or investigator’s brochure for an unauthorised investigational product). 31. Package leaflet means a leaflet containing information for the user which change accompanies the medicinal product. 32. Periodic safety update report means a periodic record intended to update the medicinal product safety data and to submit it according to the procedure established by the State Medicines Control Agency. 33. Abuse of medicinal products means persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effects. 34. Post-authorisation safety studies means pharmacological, epidemiological or clinical study performed according to the terms of marketing authorisation of medicinal product in order to establish or quantitavely assess the safety of the medicinal product. 35. Radiopharmaceutical medicinal product (hereinafter referred to as radiopharmaceutical product) means any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medical purpose. 36. Radionuclide generator means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be obtained by elution or by any other method and used in a radiopharmaceutical product. 37. Radionuclide precursor means any other radionuclide produced for the radio-labelling of another substance prior to administration. 38. Radionuclide kit means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration. 39. Medicinal product subject to medical prescription means a medicinal product assignment of which to this group of medicinal products is subject to certification by the State Medicines Control Agency or the European Medicines Agency. 40. Reference state means an EEA State which drafts the protocol of assessment of pharmaceutical, pre-clinical and clinical medicinal product research results, on the basis whereof other EEA states taking part in the procedure of mutual recognition or decentralised procedure take a decision on the granting of marketing authorisation of the medicinal product. 41. Reference medicinal product means a medicinal product granted marketing authorisation in any EEA State according to its internal legislation brought in line with the requirements of Article 6 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use, applying the provisions set in Article 8. 42. Mutual recognition procedure means procedure in the course whereof the EEA State(
5. es)in cooperation examine the application(identical applications) to recognise the granted another medicinal preparation by an EEA State. 43. Special validation means actions whereby the suitability of any procedure, process, equipment, material, activity or system is proved according to the principles of good manufacturing practice for attaining the intended results. 44. Serious effect of adverse reaction means an adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect. 45. Serious adverse event means any ontoward medical occurrence or effect that at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or in a congenital anomaly or birth defect. 46. Investigator means a doctor or a person whose scientific background and the experience in patient care meets the requirements set by the Minister of Health of the Republic of Lithuania (hereinafter referred to as the Minister of Health) for the investigation of medicinal products. The investigator shall be responsible for the conduct of a clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the leader responsible for the team and may be called the principal investigator. 47. Investigational medicinal product means a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different form the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form. 48. Manufacture of an investigational product means industrial manufacture of an investigational medicinal product or its manufacture by a method involving an industrial process 49. Traditional herbal medicinal product (hereinafter referred to as traditional herbal product) means herbal medicinal product which meets the criteria set by the Minister of Health and which may be applied the simplified herbal medicinal products registration procedure. 50. Medicine (medicinal product) means any substance or combination of substances manufactured and presented for treating or preventing disease in human beings as it meets at least one of the following criteria: 1) has properties which make it suitable for treating or preventing human diseases; 2) due to pharmacological, immunological or metabolic action may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions or to making a medical diagnosis. 51. Pharmacy means a legal person performing pharmaceutical activity covering the acquisition, keeping, sale (dispensing) of medicinal products to the ultimate consumer, provision of pharmacy services and/or manufacture, quality control of extemporaneous medicinal products. As used in this Law the term “pharmacy” does not apply to veterinary pharmacies. 52. Medicinal substance means any substance irrespective of origin which may be 1) human, e.g. human blood and human blood products; 2) animal, e.g. micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products; 3) vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts; 4) chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis. 53. Pharmacist means a person who has acquired professional qualification of a pharmacist and awarded MPharm degree or a person equated to him according to the procedure established by an institution authorised by the Government. 54. Pharmacist’s assistant (pharmacy technician) means a person who has acquired the qualification of a pharmacist’s assistant (pharmacy technician) or a person equated to him according to the procedure established by an institution authorised by the Government. 55. Manufacture of a medicinal product means industrial manufacture of a medicinal product or its manufacture applying the method embracing industrial manufacture process. 56. Permit for parallel import of medicinal product means a document issued by the State Medicines Control Agency, the holder of which is authorised to parallels import a medicinal product and to perform its marketing. 57. Parallel import of a medicinal product means import into the Republic of Lithuania outside the distribution network of the authorised distributor of the product granted marketing authorisation in another EEA Member State, which is identical to the medicinal product already granted marketing authorisation in the Republic of Lithuania or sufficiently resembling it. 58. Free sample of a medicinal product means free sample of a medicinal product not intended for use, to be provided for acquainting with it a health care professional qualified to prescribe medicinal products. 59. Name of the medicinal product means an invented name given to a medicinal product (which shall not be liable to confusion with the common name) or either a common or scientific name, together with a trade mark or the name of the holder of the marketing authorisation. 60. Registration certificate of a medicinal product (hereinafter referred to as registration certificate) means the document of the State Medicines Control Agency certifying the granting of marketing authorisation in the Republic of Lithuania for a homeopathic or traditional biological medicinal product and issued according to a simplified procedure for registering homeopathic or traditional biological products or a special registration procedure for the homeopathic medicinal products established by this Law. 61. Marketing authorisation certificate of a medicinal product (hereinafter referred to as marketing authorisation certificate) means the document of the State Medicines Control Agency certifying that a medicinal product holds marketing authorisation in the Republic of Lithuania, which is issued according to the medicinal products registration procedures established by this Law except for a simplified procedure for registering homeopathic or traditional biological products or a special registration procedure for the homeopathic medicinal products. 62. Terms of marketing authorisation of a medicinal product means the totality of data and information of the marketing authorisation and documents on the basis of which it has been issued. 63. Varying the terms of marketing authorisation of a medicinal product means a variation in the terms of a marketing authorisation of medicinal products provided for by Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation of medicinal products for human use and veterinary pharmaceuticals granted by a competent authority of a Member State or the varying of the terms of marketing authorisation not attributed to the variations, established by the Minister of Health. 64. Extension to a marketing authorisation of a medicinal product means varying the terms of a marketing authorisation of medicinal products provided for by Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of changes to the active substance, its pharmacokinetics, strength, pharmaceutical form or change or addition of a new route of administration. 65. Medicinal product marketing authorisation (hereinafter referred to as marketing authorisation) means a person’s right to organise the supply of a medicinal product to the market, advertising and marketing management measures. 66. Holder of medicinal product marketing authorisation means a legal person who has been granted the medicinal product marketing authorisation according to the requirements of legal acts. 67. Representative of the holder of medicinal product marketing authorisation means the representative appointed in the Member State by the holder of the medicinal product marketing authorisation. 68. Strength of the medicinal product means the content of the active ingredient expressed quantitatively per dosage unit, per unit of volume or weight (according to the dosage form). 69. Medicinal products means products the list of groups whereof is approved by the Minister of Health and which are allowed to be acquired, kept and sold (dispensed) in pharmacies. The term shall not cover medicinal products. 70. Advertising of medicinal products means the spread among the general public, health care professionals and pharmaceutical specialists in any form and by any means of purposive information about medicinal products, the canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products, including: 1) visits by medical sale representatives to persons qualified to prescribe medicinal products; 2) the supply of samples of medicinal products; 3) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of a benefit or bonus, whether in money or in kind; 4) sponsorship in promotional meetings, attended by health care and pharmaceutical specialists qualified to prescribe or supply medicinal products; 5) sponsorship of scientific congresses attended by health care professionals and pharmaceutical specialists qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith; 6) the support of radio, television broadcasts and/or programmes during which information about medicinal products is supplied. 71. Advertiser of medicines means a legal person authorised by the marketing authorisation holder and/or his representative to carry out advertising of medicinal products. 72. Bearer prescription medicinal product means a medicinal product to which marketing authorisation has not been granted which is indispensable for an individual patient, supplied to the Republic of Lithuania on the prescription of the patient’s doctor, submitted according to the procedure established by the Minister of Health and intended to be used under direct responsibility of the doctor. 73. Veterinary paramedic means a legal person who has acquired professional qualification of a veterinary paramedic or a professional qualification recognised as equivalent to it according to the procedure established by the institution authorised by the Government. 74. Veterinary surgeon means a person possessing a diploma certifying completion of university education according to the procedure established by n institution authorised by the Government. 75. Veterinary pharmacy means a legal person entitled to acquire, hold, sell/dispense, manufacture veterinary pharmaceuticals and control the quality thereof. 76. Veterinary pharmaceutical activity means activity of legal and/or natural persons covering the manufacture, import, supply (trade in), quality control of veterinary pharmaceutical and processing of veterinary pharmaceutical waste. 77. Veterinary pharmaceutical company means a legal person engaged in veterinary pharmaceutical business. 78. Manager of veterinary pharmaceutical activity means a natural person meeting the established requirements and appointed by a legal person holding a veterinary pharmaceutical activity licence to manage veterinary pharmaceutical activity. 79. Veterinary pharmaceuticals means any substance or combination of substances presented for treating or preventing diseases in animals or administered in animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in animals. 80. Register of veterinary pharmaceuticals means the system of storing, protection and management of data of the veterinary medicinal products authorised for use in the Republic of Lithuania. 81. Immediate packaging means the container or other form of packaging immediately in contact with the medicinal product. 82. Labelling means information on the immediate or outer packaging. CHAPTER II RECOGNITION OF QUALIFICATION OF PHARMACISTS AND PHARMACIST’S ASSISTANTS (PHARMACY TECHNICIANS), LICENSING REGISTRATION, COMPETENCE AND SUPERVISION OF QUALIFICATION Article 3. Recognition of Qualification of Pharmacists and Pharmacist’s Assistants (Pharmacy Technicians) 1. Pharmacy diplomas issued by institutions of post-secondary education and higher educational institutions of the Republic of Lithuania as well as pharmacy diplomas, certificates and other documents testifying to professional qualification recognized by an institution authorised by the Government issued in other states provided they meet the minimum requirements of pharmacy study programmes for pharmaceutical specialists valid in the European Union shall be valid in the Republic of Lithuania. 2. Professional qualification (preparedness and experience) of a pharmacist and of a pharmacist’s assistant (pharmacy technician) acquired in foreign states shall be assessed and recognised by an institution authorised by the Government. Article 4. Licensing of the Pharmacist’s Practice 1. The pharmacist may carry out the duties of a pharmacist in a community pharmacy, production community pharmacy, hospital pharmacy, production hospital pharmacy, university pharmacy and charity pharmacy only holding a pharmacist’s practice licence. 2. A pharmacist’s practice licence shall be issued for an indefinite period. 3. A pharmacist’s practice licence shall be issued, refused to be issued and revoked by the State Medicines Control Agency invoking this Law and the Rules of Licensing of Pharmacist’s Practice approved by the Minister of Health. The person aspiring to obtain a licence for pharmaceutical activity must submit an application, a diploma certifying the acquired professional qualification of a pharmacist and other documents established by the Rules of Licensing of Pharmacist’s Practice. If the person wishes to acquire a licence after the lapse of more than one year after graduation, he must also submit documents certifying that his qualification has been improved according to the procedure established by the Minister of Health. 5. The decision on the issuing of the licence or a justified refusal to issue the licence must be presented to the applicant not later than within 30 days from the receipt of all the documents. The time limit within which the applicant shall submit the missing data shall not be included in the period of decision making but if the applicant delays to specify the data the decision must be made not later than within 60 days from the receipt of documents. 6. The State Medicines Control Agency shall publish a notice on the issuance of the pharmacist’s practice licence and the revocation of the licence in the information supplement to the official gazette "Valstybės žinios". 7. A state fee of the established amount shall be paid for the issuing of the licence. 8. Issuing of a pharmacist’s practice licence shall be refused if: 1) not all documents have been submitted or if the submitted documents do not meet the established requirements, are not duly executed; 2) erroneous data has been given in the documents; 3) the person’s legal capacity has been restricted by an effective court decision; 4) the person has been prohibited from engaging in the pharmacist’s practice by an effective court decision; 5) a State fee of the established amount has not been paid. 9. The licence shall be revoked: 1) upon the request of the licence holder; 2) if the licence holder committed a violation of pharmaceutical activity resulting in heavy consequences which were determined by the institutions controlling the pharmaceutical activity; 3) if erroneous data has been submitted for the issuance of the licence; 4) if legal capacity of the licence holder has been restricted by an effective court decision; 5) if the licence holder has been prohibited by an effective court decision from engaging in the pharmaceutical activity; 6) if the licence holder failed to discharge the obligation established in Subparagraph 2 of paragraph 3 of Article 7; 7) if the licence holder dies. 10. After the revocation of the licence the pharmacist and the employer shall be within 10 days notified thereof in writing with the reasons thereof specified. 11. A new licence to engage in pharmaceutical activity may be issued on the applicant’s request upon having submitted the documents specified in the rules for licensing the pharmaceutical activity only after the lapse of 6 months from the day of the licence except in cases where the licence has been revoked by an effective court decision or the person’s legal capacity has been restricted by an effective court decision. In such case a new licence may be issued not earlier than after the expiry of the time limit specified in the court decision or after the lifting by the court of the restrictions of legal capacity. The 6 months time period shall not apply where the licence is revoked upon the request of the licence holder. 12. The decisions of the institutions issuing the licences shall be subject to appeal according to the procedure established by legal acts. Article 5. Registration of the Pharmacist’s Assistant (Pharmacy Technician) 1. The pharmacist’s assistant (pharmacy technician) shall have the right to engage in the practice of pharmacist’s assistant (pharmacy technician) in the pharmacy from the day of entry of the pharmacist’s assistant (pharmacy technician) in the List of Pharmacist’s Assistants (Pharmacy Technicians). 2. Entry in the List of Pharmacist’s Assistants (Pharmacy technicians) shall be made on the decision of the State Medicines Control Agency. The pharmacist’s assistant (pharmacy technician) shall submit to the State Medicines Control Agency an application in the established form requesting to be entered in the List of Pharmacist’s Assistants (Pharmacy Technicians), a diploma certifying the acquired professional qualification of the pharmacist’s assistant (pharmacy technician) and other documents specified by the Minister of Health. 3. State Medicines Control Agency shall take a decision to enter or to refuse entering the pharmacist’s assistant (pharmacy technician) in the List of Pharmacist’s Assistants (pharmacy technicians) no later than within 30 days from the day of receipt of the documents specified in paragraph 2 of this Article if the pharmacist’s assistant (pharmacy technician) meets the requirements laid down by this Law and the Minister of Health. 4. The applicant with respect to whom a decision is take not to enter him in the List of Pharmacist’s Assistants (Pharmacy technicians) shall have the right to appeal the decision according to the procedure established by legal acts 5. In case the contract of employment regarding the practice of the pharmacist’s assistant (pharmacy technician) is concluded with the person who is not entered in the List of Pharmacist’s Assistants (pharmacy technicians), the employer shall be held liable according to the procedure laid down by legal acts for the failure to meet the requirement set in paragraph 1 of this Article. 6. The pharmacist’s assistants (pharmacy technicians) must every 5 years submit to the State Medicines Control Agency documents confirming the improvement of professional qualification of the pharmacist’s assistant (pharmacy technician) according to the procedure laid down by the Minister of Health. 7. The applicant shall not be entered in the List if: 1) not all documents have been submitted or they do not meet the requirements, have not been duly executed; 2) erroneous data have been given in the documents; 3) the person’s legal capacity has been restricted by an effective court decision; 4) the person has been prohibited by an effective court decision from engaging in the practice of the pharmacist’s assistant (pharmacy technician). 8. The pharmacist’s assistant (pharmacy technician) is removed from the List of Pharmacist’s Assistants (Pharmacy Technicians): 1) upon his own request; 2) if the pharmacist’s assistant (pharmacy technician) is prohibited by an effective court decision from performing the activities of the pharmacist’s assistant (pharmacy technician); 3) if legal capacity of the pharmacist’s assistant (pharmacy technician) is restricted by an effective court decision; 4) if it transpires that the applicant submitted erroneous data for the entry in the list; 5) in case of failure by the pharmacist’s assistant (pharmacy technician) to discharge the duty specified in paragraph 6 of this Article; 6) in case of death of the pharmacist’s assistant (pharmacy technician). Article 6. Improvement of Qualifications of Pharmacists and Pharmacist’s Assistants (Pharmacy Technicians) 1. Improvement of qualifications of pharmacists and pharmacist’s assistants (pharmacy technicians) shall be carried out according to the procedure established by the Minister of Health by the higher educational establishments and related NGOs of the Republic of Lithuania. 2. The employees engaged in the improvement of qualifications shall be excused from work according to the procedure established in the Labour Code. Article 7. Rights and Duties of Pharmacists and Pharmacist’s Assistants (Pharmacy Technicians) 1. The rights, duties, professional competence and responsibility of pharmacists and pharmacist’s assistants (pharmacy technicians) shall be established in this Law, the schedule of rights and duties of pharmacists and pharmacist’s assistants (pharmacy technicians) approved by the Minister of Health, other legal acts, description of the posts of the pharmacist and pharmacist’s assistant (pharmacy technician). 2. The pharmacists shall have the right to: 1) engage in the pharmaceutical activity according to the procedure established by this Law and other legal acts; 2) sell/dispense to the general public medicinal products and pharmacy goods; 3) engage in extemporaneous preparation of medicinal products and quality control of such preparations; 4) receive information required for the pharmaceutical activity, when necessary cooperate with health care professionals and receive information about the medicinal products intended for patients and used by them; 5) inform and consult the residents about rational use of medicinal products, propagate healthy way of living; 6) refuse to sell/dispense medicinal products if this would be contrary to the pharmacist’s principles of professional ethics or may present direct danger to the person’s life or cause harm to his health; 7) take part in the activities of pharmacists’ professional organisations if other legal acts do not establish otherwise. 3. The pharmacist must: 1) improve his professional qualifications according to the procedure established by the Minister of Health; 2) at least once in 5 years notify the State Medicines Control Agency according to the procedure established by the rules for licensing the pharmaceutical activity of the improvement of the pharmacist’s professional qualifications and the pharmaceutical activity, if the pharmacist performs pharmaceutical activities in the pharmacy; 3) respect the principles of pharmacist’s professional ethics; 4) fulfil other duties established by legal acts. 4. The pharmacist’s assistant (pharmacy technician) shall have the right to: 1) engage in the practice of the pharmacist’s assistant (pharmacy technician) according to the procedure established in this Law and other legal acts; 2) sell pharmacy goods, provide information about the conditions of their use or storing, sell/dispense medicinal products under the control of the pharmacist; 3) manufacture extemporaneous medicinal products; 4) manage stocks of medicinal products and pharmacy goods; 5) receive information necessary for the performance of practice of the pharmacist’s assistant (pharmacy technician); 6) take part in the activities of professional organisations of pharmacist’s assistants (pharmacy technicians) if other legal acts do not establish otherwise. 5. The pharmacist’s assistant (pharmacy technician)must: 1) improve his professional qualification according to the procedure established by the Minister of Health; 2) respect the principles of pharmacist’s professional ethics; 3) performing the practice of the pharmacist’s assistant (pharmacy technician) cooperate with pharmacists and health care professionals; 4) perform other duties established by legal acts. 6. The pharmacist and the pharmacist’s assistant (pharmacy technician) shall also have other rights established by other legal acts. CHAPTER III SUPPLY OF MEDICINAL PRODUCTS TO THE MARKET Article 8. General Provisions 1. Medicinal products manufactured industrially or by a method involving an industrial process may be supplied to the market of the Republic of Lithuania only if registered in the Register of Medicinal Products of the Republic of Lithuania, in the Community Code of Medicinal Products or entered in the List of Parallelly Imported Medicinal Products (hereinafter referred to as medicinal products granted marketing authorisation). 2. The marketing authorisation requirement shall also apply to radionuclide generators, sets of radionuclides, radiopharmaceutical products – radionuclide precursors and industrially manufactured radiopharmaceutical products. 3. The following medicinal products not granted marketing authorisation may be supplied to the market of the Republic of Lithuania and used for health care according to the procedure established by the Minister of Health: 1) the necessary medicinal products if they have been granted marketing authorisation in any EEA state; 2) bearer prescription medicinal products where the doctor prescribing them for the use of a single patient assumes direct and personal responsibility. 4. Only legal persons who have received a wholesale distribution licence according to the procedure established by this Law may bring into the Republic of Lithuania from another EEA state medicinal products not granted marketing authorisation or import from a third country bearer prescription medicinal products. 5. The Minister of Health may provisionally grant an authorisation to place on the market of the Republic of Lithuania medicinal products not granted marketing authorisation that are necessary to be used when pathogenic or chemical factors, toxins or ionising radiation posing a health hazard is suspected or established, also if a natural disaster occurs. 6. Without derogating from the requirements of the procedure of supply of bearer prescription medicinal products laid down by the Minister of Health, the holders of the marketing authorisation, the manufacturers and health care professionals shall not be held liable for the consequences of the use of medicinal products not granted marketing authorisation or medicinal products which have been granted marketing authorisation without approved indications, if recommended or instructed to use them by the Ministry of Health, having suspected or established the presence of pathogenic or chemical factors, toxins or ionising radiation which pose a danger to health or after the happening of a natural disaster. The above provision shall not apply in the cases established in the Civil Code of the Republic of Lithuania regarding the products of inferior quality. 7. The requirements of marketing authorisation, manufacturing, wholesale distribution, advertising of a medicinal product and pharmacovigilance in respect of the medicinal product established by this Law shall not be applied with respect to: 1) interim products intended for processing in the legal entities holding the manufacturing licence issued according to the procedure established by this Law; 2) radionuclides in the form of sealed sources; 3) whole blood, plasma or blood cells of human origin, except for plasma manufactured applying the method embracing industrial manufacture process. 8. The marketing authorisation requirement shall not apply with respect to radiopharmaceutical products manufactured in accordance with the manufacturer’s instructions exclusively from authorised radionuclide generators, radionuclide kits or radionuclide precursors prior to its use in the health care establishment holding an authorisation to work with the sources of ionising radiation. 9. Legal persons in possession of a licence for the provision of personal health care services may acquire medicinal products only from legal persons holding a licence for manufacturing or a wholesale distribution licence, and the Magistral Formula – from production community pharmacy. These legal persons shall keep and enter the acquired medicinal products in the records according to the procedure established by the Minister of Health. 10. The legal persons who are not in possession of a licence for the provision of personal health care services or licence to engage in pharmaceutical activity may acquire medicinal products only from pharmacies. 11. The rules for filling prescriptions for medicinal products and for dispensing (selling) medicinal products to the general public shall be approved by the Minister of Health. 12. Medicinal products subject to medical prescription shall be dispensed (sold) to patients undergoing outpatient treatment only on the doctors’ prescription. 13. A natural person shall have the right to import to the Republic of Lithuania for his own needs and to take out of the Republic of Lithuania, to receive or send by post medicinal products according to the procedure established by the Minister of Health. 14. It shall be prohibited to manufacture, import, distribute and place on the market counterfeit medicinal products. The monitoring of counterfeit medicinal products shall be coordinated by the institution authorised by the Government of the Republic of Lithuania. Products which are deliberately fraudulently mislabelled with respect to identity an/or origin shall be considered counterfeit medicinal products. 15. The Ministry of Health or the institution authorised by it shall: 1) organise and coordinate the supply of the Lithuanian population with the basic medicinal products, regulate and ensure by legal and organisational measures uninterrupted supply to the pharmacies of the country of Article 9. Granting of Medicinal Product Marketing Authorisation 1. Medicinal product marketing authorisation shall be granted in a EEA state by the authorised institution of that state and in all EU Member States (hereinafter in the Community) – by the European Commission. 2. The State Medicines Control Agency shall issue in the Republic of Lithuania medicinal product marketing authorisation and marketing authorisation licences, shall renew the marketing authorisation of medicinal products, certify the supplements to the licences and variations to their terms, suspend thee licence, lift the suspension of the licence or revoke the licence and manage the Register of Medicinal Products of the Republic of Lithuania according to the procedure established by the Minister of Health. The variations to the terms of a marketing authorisation of medicinal products for human use and veterinary medicinal products shall be certified according to the procedure established in the Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation of medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State 3. The marketing authorisation shall be granted to a medicinal product of a certain strength and pharmaceutical form. Other strengths, pharmaceutical forms, methods of administration, presentations (e.g. the number of dosage units in the package and the package design), supplements to and variation of the marketing certificate shall be within the scope of general marketing law. The periods of data and market exclusiveness specified in paragraphs 5 and 6 of Article 11 of this Law shall be counted from the day of granting of the initial marketing authorisation (hereinafter referred to as primary marketing authorisation). 4. Medicinal product marketing authorisation may be granted to persons who have been established in any EEA state and meet the requirements established by this Law and other legal acts. 5. Being granted a medicinal product marketing authorisation shall not exempt the manufacturer of the medicinal product and holder of the medicinal product manufacturing authorisation from liability established in legal acts. 6. Where, taking into account all its characteristics, a product may fall within the definition of “a medicinal product” and within the definition of a product covered by other legislation of the Republic of Lithuania, the requirements applicable to a medicinal product shall apply. 7. Marketing authorisation shall be ceded according to the procedure established by the Minister of Health. 8. The State Medicines Control Agency when granting the marketing authorisation shall classify the medicinal products into medicinal products subject to medicinal prescription and those not subject to medicinal prescription. To this end the criteria laid down in Article 10 of this Law shall apply. The classification group may be changed by renewing the marketing authorisation of the medicinal product or by changing the classification based on the criteria set in this Law and in the European Commission recommendations on changing the classification of medicinal products intended for human use. 9. The State Medicines Control Agency shall approve and publish the list of medicinal product which are subject to prescription and shall update the list annually and notify the European Commission and other EEA states of the amendments of the list. Article 10. Criteria for Classification of Medicinal Products 1. Medicinal products shall be classified as those subject to medicinal prescription and those not subject to medicinal prescription. 2. Assigned to medicinal products subject to medicinal prescription shall be those medicinal products which meet the following criteria: 1) they are likely to present a danger either directly or indirectly, if utilised without medical supervision; 2) they are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health; 3) they contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation; 4) they are normally prescribed by a doctor to be administered parenterally; 5) the medicinal products, because of their pharmaceutical characteristics or novelty or in the interests of public health, are reserved for treatments which can only be followed in a hospital environment; 6) the medicinal products are used in the treatment of conditions which must be diagnosed in a hospital environment or in institutions with adequate diagnostic facilities (although administration and follow-up may be carried out elsewhere); 7) the medicinal products are intended for outpatients but their use may produce very serious adverse reactions requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment. 3. The sub-category of medicinal products subject to special medical prescription shall be provided for in the group of medicinal products subject to medical prescription. Attributed to the sub-category shall be medicinal products corresponding to at least one of the following criteria: 1) the medicinal product contains a substance classified as a narcotic or a psychotropic substance entered in List II of Narcotic and Psychotropic Substances certified by the Minister of Health (narcotic and psychotropic substances permitted to be used for medical purposes); 2) if incorrectly used, the medicinal product is likely to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes, 3) the medicinal product contains a substance which, by reason of its novelty or properties, could be considered, as a precautionary measure, as belonging to the group envisaged in subparagraph 2 of paragraph 3 of this Article . 4. Medicinal products not corresponding to the criteria laid down in paragraphs 2 and/or 3 of this Article shall be assigned to the sub-category of medicinal products not subject to subscription. Article 11. Submitting an Application for Marketing Authorisation 1. The person who wishes to be granted marketing authorisation simultaneously in several EEA states for a medicinal product not granted marketing authorisation in EEA states, including the Republic of Lithuania, must submit to the State Medicines Control Agency an application to be granted the marketing authorisation according to the decentralised procedure and the dossier identical to that which is submitted to the competent authority/authorities of another state/other states. 2. The person who wishes to be granted marketing authorisation of a medicinal product in any EEA state, including the Republic of Lithuania, must submit an application to the State Medicines Control Agency to be granted marketing authorisation for a medicinal product according to the mutual recognition procedure and the dossier identical to that based whereon the medicinal product was granted marketing authorisation by the first state with all the subsequent supplements. 3. The person who wishes to be granted marketing authorisation of a medicinal product only in the Republic of Lithuania while in another EEA state or other EEA states this medicinal product has not been granted marketing authorisation must submit to the State Medicines Control Agency an application for granting the medicinal product marketing authorisation according to the national procedure. 4. Pharmaceutical (physical-chemical, biological or microbiological) pre-clinical (toxicological and pharmaceutical) test and clinical trial results must be submitted alongside the application in addition to other documents and information prescribed by the Minister of Health. 5. Without prejudice to the protection of industrial property and commercial secrecy, the applicant is not required to provide the results of pre-clinical tests and clinical trials if he can demonstrate that the medicinal product presented for marketing authorisation is a generic medicinal product of a reference medicinal product which is or has been authorised for not less than 8 years in a EEA state or in the Community. This period shall stand for the period of data exclusivity of the reference medicinal product. 6. Generic medicinal product granted marketing authorisation under paragraph 5 of this Article may be supplied to the market after the lapse of not less than 10 years from the day of granting the reference medicinal product initial marketing authorisation. The two-year period counted after the period of data exclusivity shall stand for the reference medicinal product market exclusivity period. 7. The 10-year exclusivity period referred to in paragraph 6 of this Article shall be extended for not longer than one more year if during the initial 8 years of the specified 10 years the marketing authorisation holder registers one or several new therapeutic indications which according to scientific evaluation performed prior to the granting of marketing authorisation are considered as affording substantial clinical benefit compared with the present treatment. 8. In the application of paragraphs 5-7 of this Law, the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines announced by the EU institutions. 9. Paragraphs 5–7 of this Article shall not apply with respect to reference medicinal products applications for granting marketing authorisation for which were submitted before 9 January 2005. If the applications for granting marketing authorisation for reference medicinal products were submitted before the intended date, without prejudice to the protection of industrial property and commercial secrecy the results of pre-clinical tests and clinical trials need not be submitted if it is demonstrated that the medicinal product presented for granting marketing authorisation is a generic medicinal product of a reference medicinal product which is or has been granted marketing authorisation in the Community for not less than 10 years or in any EEA state for not less than 6 or 10 years taking into account the period of data exclusivity established by that state. 10. If a medicinal product does not correspond to the term “generic medicinal product” or its bioequivalence cannot be demonstrated by appropriate bioavailability studies or if active substance(s), therapeutic indications, strengths, pharmaceutical form or route of administration (compared to reference medicinal product) is subject to modification, results of appropriate pre-clinical tests or clinical trials must be presented. 11. If a biological medicinal product similar to a reference biological medicinal product does not correspond to the term of generic medicinal product because of the difference in stocks or manufacturing processes, results of appropriate pre-clinical tests or clinical trials must be presented. Additionally presented information must comply to the analytical, pharmaco-toxicological and clinical trials of medicinal products standards, protocols and appropriate guidelines in respect of the testing of proprietary medicinal products established by the Minister of Health. The results of other trials which are in the marketing authorisation dossier of reference medicinal product need not be presented. 12. An additional not summed up one year period of data exclusivity shall be granted to a new indication of active substance of recognised medical use, if substantial pre-clinical tests and clinical trials have been conducted in respect of it. 13. The performance of necessary studies and trials in order to submit an application for the marketing authorisation in the Republic of Lithuania of a medicinal product according to paragraphs 5, 10 and 11 of this Article or in the Community Code of Medicinal Products according to the requirements laid down in Regulation (EC) No 726/2004 or in other states according to legal requirements of those states and the related practical needs shall be without prejudice to the rights granted by the medicinal product patent or by a supplementary protection certificate provided for in the Patent Law of the Republic of Lithuania and in other legal acts regulating the protection of industrial property. 14. Without prejudice to the legal acts regulating the protection of industrial property and commercial secrecy, the results of pre-clinical tests or clinical trials need not be submitted if it is demonstrated that the use in the Community medical practice of the active substance(substances) of the medicinal product presented for the granting of marketing authorisation has been recognised for not less than 10 years and its efficacy and acceptable safety has been proved based on the requirements of the standards and protocols of analytical, pharmaco-toxicological and clinical trials of medicinal products established by the Minister of Health. In this case appropriate scientific literature shall be presented instead of results of pre-clinical tests and clinical trials. 15. If the active substances of the medicinal product submitted for granting marketing authorisation have been included in the composition of the medicinal products formerly granted marketing authorisation but their composition has not been used for therapeutic purposes, the results of new pre-clinical tests and clinical trials of the combination shall be presented. Reference to scientific data regarding every active substance need not be presented. 16. The holder of the marketing authorisation of a medicinal product may permit to use the pharmaceutical, pre-clinical and clinical documents presented in the marketing authorisation dossier of the product registered in his name for considering marketing authorisation applications of subsequently presented medicinal products having identical qualitative and quantitative composition and pharmaceutical form of active substances. 17. A person must submit all clinical and/or scientific literature particulars, whether favourable or unfavourable to the product. The information must be presented in such a manner as to allow to adopt a scientifically justified decision regarding the issuing of the marketing authorisation and its terms. 18. The applicant or the marketing authorisation holder shall be liable for the accuracy of the supplied information, particulars and documents. Article 12. Examination of the Application for Marketing Authorisation of a Medicinal Product and Issuing of Marketing Authorisation Certificate 1. Upon receiving an application for the marketing authorisation of a medicinal product the State Medicines Control Agency shall: 1) evaluate the documents and information submitted together with the application, draw the conclusion whether they meet the requirements established for granting the marketing authorisation; 2) may submit a medicinal product, its starting materials and, if need be, its intermediate products or other constituent materials for testing by the Medicines Control Laboratory of the State Medicines Control Agency, in order to ensure that the control methods employed by the manufacturer and described in the particulars accompanying the application are satisfactory; 3) may require the applicant to supplement the documents and information accompanying the application; 4) ascertain that the manufacturer and/or importer can avail himself of the option to manufacture and/or control the medicinal product according to the methods described in the documents accompanying the application for marketing authorisation; after the applicant submits a justified request, the State Medicines Control Agency may allow to have certain stages of manufacture and/or controls to be carried out by the third parties which meet the requirements. 2. The marketing authorisation of a medicinal product shall be granted or a justified refusal to grant the marketing authorisation shall be given not later than within 210 days from the day of receipt of the application submitted according to the established requirements. The time within which the applicant provides additional documents, information and, as necessary, verbal and/or written explanations required by the State Medicines Control Agency shall not be included in the time of examination of the application. 3. Upon taking a decision to grant marketing authorisation of the medicinal product, the State Medicines Control Agency shall: 1) issue the applicant the certificate of marketing authorisation of the medicinal product with the following supplements: summary of the product characteristics, the terms of the marketing authorisation, labelling and packing leaflet; 2) enter the medicinal product in the Register of Medicinal Products of the Republic of Lithuania; 3) classify the medicinal product as a medicinal product not subject to medical prescription or as a medicinal product subject to medicinal prescription in accordance with medicinal products classification criteria established by this Law; 4) publish in the media a notice of the granting of marketing authorisation of the medicinal product and the summary of the product characteristics; 5) draw up the protocol of assessment of documents of pharmaceutical, pre-clinical tests and clinical trials of the medicinal product; it shall be updated whenever new information becomes available about the quality, safety or efficacy of the medicinal product concerned; 6) immediately allow public access to the contents of assessment protocol, save confidential commercial type information. A justified decision to grant marketing authorisation shall accompany the assessment protocol and each indication shall be separately discussed. 4. A State fee of the established amount shall be payable for the examination of the application to grant marketing authorisation of a medicinal product, the accompanying documents and information and also for the issuance of marketing authorisation certificate. 5. If the State Medicines Control Agency, upon having received the application for the granting of the marketing authorisation of a medicinal product, when applying the procedure established by legal acts of the Republic of Lithuania (national procedure) establishes that the application for the granting of the marketing authorisation of the same medicinal product is being examined in another EEA state, the application shall not be considered and the applicant shall be offered to submit it under decentralised procedure. 6. If the State Medicines Control Agency, upon having received the application for the granting of the marketing authorisation of a medicinal product, when applying the national procedure establishes that the marketing authorisation of the same medicinal product has been granted in another EEA state, the application shall not be considered and the applicant shall be offered to file it according to the mutual recognition procedure. 7. Information about the submitted or considered applications for granting marketing authorisation of medicinal products or varying of the terms of marketing authorisation is confidential and not subject to publication except in cases when the disclosure of the information is required by the laws of the Republic of Lithuania or the regulations of the European Union. Article 13. Refusal to Grant Marketing Authorisation of the Medicinal Product Marketing authorisation of a medicinal product shall not be granted if upon examining the application, documents and information submitted by the applicant at least one of the following grounds is established:: 1) unfavourable benefit/risk balance; 2) the applicant failed to fully substantiate the efficacy of the medicinal product; 3) the quantitative and/or qualitative composition of the medicinal product does not correspond to the declared composition 4) information and documents accompanying the application do not correspond to the requirements set by the Minister of Health; 5) a State fee of the established amount have not been paid. Article 14. Validity and Renewal of the Marketing Authorisation 1. Marketing authorisation of the medicinal product shall be granted for the period of 5 years. 2. The application for the renewal of the marketing authorisation of a medicinal product must be submitted by its holder not later than 6 months before the expiry of its validity. 3. Together with the application for the renewal of the marketing authorisation its holder must submit a consolidated dossier covering the quality, safety, efficacy of the medicinal product and all the variations approved upon granting the marketing authorisation. 4. The State Medicines Control Agency shall renew the marketing authorisation of the medicinal product if its benefit/risk balance is again assessed favourably. 5. The marketing authorisation of a medicinal product renewed according to the procedure established by this Law and other legal acts shall be valid for an indefinite period except where the State Medicines Control Agency decides based on good reasons related to pharmacovigilance that after another 5-year period it must be repeatedly renewed. 6. If having been granted the marketing authorisation the medicinal product is not placed on the market within a 3-year period or if the medicinal product which already used to be placed on the market is not on the market for 3 years in succession the marketing authorisation shall be revoked. 7. In exceptional cases, in the interest of public health the State Medicines Control Agency may refrain from revoking marketing authorisation of a medicinal product which has not been placed on the market under paragraph 6 of this Article. 8. The holder of the marketing authorisation of a medicinal product shall pay a State fee of the established amount for the examination of the application when updating the marketing authorisation, assessment of the benefit/risk balance based on the periodically updated safety protocol and other documents and information (except in cases when the protocols are submitted immediately on the request of the State Medicines Control Agency. Article 15. Obligations and Liability of a Marketing Authorisation Holder 1. After the marketing authorisation has been granted, its holder, taking into account the scientific and technical progress, must, as necessary, introduce any changes that may be required to enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods. 2. Changes in the manufacture and checking methods shall be subject to the approval by the State Medicines Control Agency according to the procedure established by the Minister of Health. 3. The holder of the marketing authorisation of a medicinal product must ensure that the information submitted in the summary of product characteristics corresponds to the approved information after the granting of the marketing authorisation. 4. If the manufacturer of the medicinal product is not the marketing authorisation holder, he must submit, at the request of the State Medicines Control Agency, proof of control of the constituents of the medicinal product and/or control tests carried out at intermediate stages of the manufacturing process carried out according to information accompanying an application for marketing authorisation; 5. The holder of the marketing authorisation of a medicinal product must immediately submit to the State Medicines Control Agency all new information that may require supplementing the summary of the product characteristics, the terms of the marketing authorisation, labelling, package leaflet or other documents and information accompanying an application for marketing authorisation, especially where restrictions or prohibitions were placed on the medicinal product by a competent authority of any other state and submit all the new information that may affect the assessment of benefit/risk balance of the medicinal product. 6. The State Medicines Control Agency may require at any time that the marketing authorisation holder submits particulars in proof that the benefit/risk balance remains favourable. 7. Upon granting the marketing authorisation of a medicinal product its holder must within 6 months notify the State Medicines Control Agency of the date of first placing of the product on the market of the Republic of Lithuania and in cooperation with the distributor ensure proper supply of required frequency in keeping with the patients’ demand. 8. Not less than two months before the intended temporary or permanent termination of supply to the market of the Republic of Lithuania of a medicinal product its marketing authorisation holder must notify the State Medicines Control Agency thereof. 9. The holder of the marketing authorisation, before supplying to the market series of immunological products and/or products derived from blood, shall submit samples of each batch for testing by the State Medicines Control Agency, except in cases where the control of the batch is performed in the official medicines control laboratory of another EEA state or in the laboratory designated for that purpose which confirms that the batch is in conformity with the quality control documents submitted with the application for marketing authorisation. In this case the State Medicines Control Agency shall be submitted a copy of certificate of release into free circulation by the EEA official control authority. 10. The marketing authorisation holder must ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from human blood or human plasma are properly validated, attain batch-to-batch consistency and guarantee, insofar as the state of technology permits, the absence of specific viral contamination. He must notify the State Medicines Control Agency of the methods used to reduce or eliminate pathogenic viruses liable to be transmitted by medicinal products derived from human blood or human plasma and at its request submit samples of the bulk and/or the medicinal product 11. At the request of the State Medicines Control Agency, especially when it is necessary for reasons related to pharmacovigilance, the marketing authorisation holder must submit to it all data about the amount of the medicinal product marketed and the available data about the amount of the medicinal product prescribed. 12. If the marketing authorisation of a medicinal product is suspended under Article 66 of this Law, the marketing authorisation holder must notify thereof the wholesale distribution enterprise, pharmaceutical and health care institutions which have acquired the product. 13. If the marketing authorisation of a medicinal product is revoked, the marketing authorisation holder, cooperating with wholesale distribution enterprises, must immediately withdraw the medicinal product from the market. 14. The marketing authorisation holder shall be responsible for the marketing of the medicinal product; the appointment of the representative shall not relieve the marketing authorisation holder of responsibility according to the procedure set by legal acts. Article 16. Specifics of Supply to the Market of Homeopathic and Traditional Biological Medicinal Products 1. Homeopathic medicinal products which satisfy the criteria set by the Minister of Health shall be subject to a simplified homeopathic medicinal product registration procedure established by the Minister of Health. The pharmacovigilance requirements shall not be applied with respect to the products. 2. Taking into account the traditions of homeopathy and the health care needs of the Republic of Lithuania the Minister of Health may approve for homeopathic medicinal products, except for those referred to in paragraph 1 of this Article, a special registration procedure laying down specific requirements for pre-clinical tests and clinical trials. If the procedure is approved the European Commission shall be notified thereof. 3. Homeopathic medicinal products that are not referred to in paragraphs 1 and 2 of this Article shall be registered according to the procedure established in Article 11 of this Law, 4. A simplified registration procedure shall be applied to traditional biological medicinal products that satisfy the criteria set by the Minister of Health, unless the State Medicines Control Agency decides that the medicinal product satisfies the criteria for registration under Article 11 of this Law. 5. Where the traditional biological medicinal product meets the criteria established by the Minister of Health to homeopathic medicinal products which may be registered according to the simplified homeopathic medicinal product registration procedure, it shall be registered according to the procedure. 6. After the State Medicines Control Agency takes a decision to register the medicinal products referred to in this Article, they shall be entered in the Register of Medicinal Products of the Republic of Lithuania and the registration certificate shall be issued. Article 17. Parallel Import of Medicinal Products 1. Parallelly imported to the Republic of Lithuania may be medicinal products which are registered in the List of Parallelly Imported Medicinal Products and in respect of which a permit for parallel import has been issued 2. The State Medicines Control Agency shall, according to the procedure established by this Law and the Minister of Health, administer the List of Parallely Imported Medicinal Products, marketing authorisation of the parallelly imported medicinal products, approve the terms of variation of the permits for parallel import, suspend the permit validity, revoke the suspension of validity and the permit validity. 3. A permit for parallel import may be issued to a medicinal product which is identical to the medicinal product already registered in the Republic of Lithuania or sufficiently resembling it. 4. A medicinal product shall be considered sufficiently resembling a medicinal product registered in the Republic of Lithuania if it meets the following criteria: 1) the same active substance and the same salt of the active substance, the same ester, ether, isomer or mixtures of isomers, complexes or derivatives of an active substance of isomers; 2) the same strength; 3) the same pharmaceutical form and administration method; 4) the same clinical and pharmaceutical properties; 5) the same or related marketing authorisation holder and/or the same manufacturer. 5. Upon taking a decision to register the medicinal product the State Medicines Control Agency shall: 1) designate the parallely imported medicinal product to subcategories subject to medicinal prescription or those not subject to medicinal prescription; 2) issue a permit for parallel import of a medicinal product with the following supplements: summary of the product characteristics, labelling and packing leaflet; 3) enter the medicinal product in the List of Parallelly Imported Medicinal Products. 6. A permit for parallel import of a medicinal product may be issued only to a legal person who has received a wholesale distribution licence issued according to the procedure established by this Law. 7. A permit for parallel import of a medicinal product shall be issued or a justified refusal to issue one shall be taken within 45 days from the day of acceptance of the application and documents submitted according to the requirements established by the Minister of Health. The time within which the applicant provides additional documents, information and, as necessary, verbal and/or written explanations required by the State Medicines Control Agency shall not be included in the time of examination of the application. 8. A permit for parallel import shall be issued for 5 years. A medicinal product imported parallelly shall be re-registered issuing a new authorisation of parallel import according to the procedure established by the Minister of Health. 9. State fee shall be paid for filing the application to register, re-register a parallelly imported medicinal product or to change the terms of the permit of parallel import, for expert examination of the documents and information submitted together as well as for the issue of the permit for parallel import. 10. Only the holder of the permit for parallel import of a medicinal product shall have the right to parallelly import the medicinal product into the Republic of Lithuania. 11. The holder of the permit for parallel import must not later than 30 days before the intended import notify in writing the marketing authorisation holder and the State Medicines Control Agency of his intention to parallelly import the medicinal product. 12. The holder of the permit for parallel import must fulfil the obligations of the marketing authorisation holder related in this Law and other legal acts to pharmacovigilance and withdrawal of the medicinal product from the market. 13. Other requirements related to parallel import and other duties of the holder of the permit for parallel import shall be established by the Minister of Health. CHAPTER IV CLINICAL TRIALS OF MEDICINAL PRODUCTS Article 18. Requirements of Clinical Trials of a Medicinal Product 1. Clinical trials of a medicinal product shall be regulated by legal acts of the Republic of Lithuania. Compliance with them shall be controlled by the State Medicines Control Agency and other institutions authorised under laws. 2. The qualification of the principal investigator must correspond to the qualification requirements established by the Minister of Health. 3. All clinical trials of medicinal products shall be designed, conducted, registered and reported according to the regulations of Good Clinical Practice approved by the Minister of Health. 4. Clinical trials of a medicinal product may be conducted only being in possession of the approval of the Lithuanian Bioethics Committee and the authorisation of the State Medicines Control Agency. The procedure for issuing certificates of approval of the conduct of a medicinal product clinical trial and of issuing authorisations for the conduct of a medicinal product clinical trial shall be established by the Minister of Health. 5. The investigational medicinal products shall be acquired and issued for clinical trials according to the procedure established by the Minister of Health. 6. The sponsor of the clinical trial or his representative and/or principal investigator, wishing to be issued a certificate of approval or authorisation of the conduct of clinical trials of medicinal products must submit documents the list whereof shall be approved by the Minister of Health. State fee of the established amount shall be paid for expert examination of the documents submitted in order to be issued a certificate of approval of the Lithuanian Bioethics Committee and the authorisation of State Medicines Control Agency and the issue of certificates of approval and authorisations. 7. The Lithuanian Bioethics Committee shall express its approval or disapproval of the conduct of clinical trials not later than within 60 days after the day of acceptance of the application. The State Medicines Control Agency shall issue an authorisation to conduct the clinical trial or shall present a justified refusal to issue one not later than within 60 days after the acceptance of the application. It may issue an authorisation of the conduct of a clinical trial only with the approval of the Lithuanian Bioethics Committee 8. The time limit specified in paragraph 7 of this Article may be extended for 30 days in the cases when it is requested to grant authorisation of trials in which the following investigational medicinal products are used. 1) investigational medicinal products intended for gene therapy; 2) investigational medicinal products intended for somatic cell therapy; 3) investigational medicinal products containing genetically modified organisms. 9. In case consultations with experts are held, the authorisation period to commence clinical trials with investigational medicinal products referred to in paragraph 8 of this Article may be extended for 90 additional days with the total period amounting to 180 days. In the case of xenogenic cell therapy, there shall be no time limit to the authorisation period. 10. The State Medicines Control Agency shall enter the data about clinical trial of a medicinal product into the European Database EudraCT according to the standard operating procedure approved by the State Medicines Control Agency, prepared according to comprehensive recommendations of the European Commission. 11. If the State Medicines Control Agency or the Lithuanian Bioethics Committee have objective grounds for considering that the application for the authorisation to conduct a clinical trial of medicinal product does not meet the requirements set by the Minister of Health or has information raising doubts about the safety or scientific validity of the clinical trial, they may refuse to issue the authorisation to conduct a clinical trial of medicinal product or the certificate of approval and shall notify the sponsor thereof. 12. The sponsor must submit to the State Medicines Control Agency and Lithuanian Bioethics Committee according to the procedure established by the Minister of Health all the received important information about the occurrence in the course of a clinical trial of adverse events or the suspected adverse reaction to an investigational medicinal product. 13. The State Medicines Control Agency shall control that data about any suspected unexpected serious adverse reactions related to an investigational medicinal product observed in Lithuania in the course of clinical trial be immediately included in the report on the suspected unexpected serious adverse reactions and in the handling of the information within the EEA in the EudraVigilance clinical trials module according to the procedure established by the Minister of Health. 14. The State Medicines Control Agency may take a decision to suspend or terminate in the country clinical trials of a medicinal product when it is already being conducted, if it has reasonable grounds to decide that the conditions of the authorisation are not being met or if there are doubts about the safety or scientific validity of the clinical trial and indicate the reasons of the decision. The sponsor and the investigator must immediately analyse the causes for suspension or termination and present a report within a week’s time analysing the posed question and all the exceptional circumstances contradicting further conduct of clinical trial of the medicinal product. Having received the report the State Medicines Control Agency shall take a decision regarding the suspension of the trial, revocation of suspension or termination of the trial. 15. After the Lithuanian Bioethics Committee decides to suspend or terminate the validity of the certificate of approval, the State Medicines Control Agency shall not later than within 7 days adopt a decision to suspend or terminate the trial. CHAPTER V LICENSING OF PHARMACEUTICAL ACTIVITY Article 19. Licensing of Pharmaceutical Activity 1. The manufacture, import of medicinal products, investigational medicinal products, wholesale distribution of medicinal products, active substances, activities and management of pharmaceutical waste (except for its disposal) shall be pharmacy activities subject to licensing. 2. Legal persons and foreign subsidiaries of legal persons (hereinafter referred to as legal person) shall be issued the following types of licences: 1) manufacturing licence; 2) wholesale distribution licence; 3) licence for pharmaceutical activity; 4) licence for manufacturing pharmaceutical activity; 5) licence for pharmaceutical waste management of (except for its disposal). 3. Licences shall be issued, changed, suspended, their validity shall be suspended or the suspension of validity shall be revoked, the changed information and/or data shall be entered in the documents submitted for the issuance of a licence by the State Medicines Control Agency Rules for licensing of pharmaceutical activities shall be approved by the Government. Article 20. Issue of Licences 1. A legal person who wishes to obtain a licence must file an application and other documents prescribed in the rules of licensing of pharmaceutical activity. The applicant shall be responsible for the accuracy of the application, submitted data and information 2. The employees of the State Medicines Control Agency, performing the actions of control, must visit the place of action referred to in the application in order to check the accuracy and correctness of the submitted data and information, to assess whether the legal person is ready according to the procedure established by legal acts to perform pharmaceutical activity. 3. The State Medicines Control Agency shall adopt a decision to issue a licence only having ascertained that the submitted data and information are in keeping with the requirements established by this Law, Rules of Licensing of Pharmaceutical Activity, Orders of the Minister of Health and other legal acts. 4. A licence shall be issued within the time limits specified in this Law. As necessary, the State Medicines Control Agency shall be entitled to ask the applicant to submit more detailed information related to the adoption of the decision as well as the approval of the person intended to perform the duties established in Article 29 of this Law whose qualification and experience are established in Article 28 of this Law or the person whose duties, qualification and experience are established in Article 34 of this Law. The applicant must submit the information not later than within 30 days. The time period within which the applicant shall submit the information shall not be included in the time period of adoption of the decision concerning the issue of the licence within the time limits established by this Law. 5. At the request of the State Medicines Control Agency State and municipal institutions as well as other persons must forthwith submit to it the available information about the founders, shareholders and heads of the branch of a legal person or foreign legal person, the legal person’s financial situation, activities, the established violations of laws and other legal acts, conclusions of conducted verifications and examinations as well as other information required by the State Medicines Control Agency for the taking of a decision on the issue of a licence. 6. The State Medicines Control Agency shall notify the Register of Legal Entities of the issue, replacement, suspension, revocation of suspension of licences or revocation of licences according to the procedure established in the Regulations of the Register of Legal Entities, shall publish a notice to the effect in the information supplement to the official gazette “Valstybės žinios” and in the Internet home page of the State Medicines Control Agency., 7. A licence shall be issued for an indefinite period of time. 8. State fee of the established amount shall be payable for the assessment of the legal entity’s preparedness to perform pharmaceutical activity according to the procedure established by legal acts as well as for the issuance of the licence. Article 21. Changing of Information and Data in the Documents Submitted by the Licence Holder for the issuance of the Licence 1. If the licence holder wants to change information and/or data in the documents submitted in order to obtain his licence (hereinafter referred to as licence information and data), he must submit to the State Medicines Control Agency an application of the form established by the Minister of Health and documents certifying the licence information and data being changed. 2. The State Medicines Control Agency, having received the application, shall have the right to go to the declared place and check the preparedness of the legal person to perform pharmaceutical activity under new conditions. 3. The decision on the licence information and data being changed shall be taken not later than within 30 days of the submission of the application and documents, except in cases provided for in this Law, Article 26 paragraph 3 and Article 32 paragraph 3. 4. The State Medicines Control Agency may request the applicant to submit more detailed information related to decision making. The applicant must submit the information not later than within 30 days. The time period within which the applicant presents the information shall not be included in the period of decision making. Article 22. Refusal to Issue a Licence, to Enter the Changed Licence Data and Information A licence shall not be issued or the entry of the changed licence data and information shall be refused if: 1) the submitted application and documents are not in keeping with the requirements set by this Law and other legal acts 2) the applicant fails to submit additional information within the established time period; 3) the applicant or the pharmaceutical activity performed by him is not in keeping with the requirements established by this Law and other legal acts; 4) bankruptcy proceedings have been instituted against the applicant; 5) a State fee of the established amount have not been paid; 6) licence has been revoked for a legal person and 6 months have not lapsed from the revocation of the licence (the provision shall not be applied when the licence holder terminates the activity subject to licensing and submits to the State Medicines Control Agency an application to revoke the licence). Article 23. Suspension of the Licence, Revocation of Suspension of the Licence or Revocation of the Licence 1. The licence shall be suspended if the performed activity is not in keeping with the licence information and data, the conditions of the activity subject to licensing are not satisfied. 2. The suspension of the licence shall be revoked when the State Medicines Control Agency, having received the licence holder’s written report of the eliminated violations of licensed activity conditions, establishes that the applicant has actually eliminated the specified violations. 3. The licence shall be revoked if: 1) the licence holder terminates the licensed activity and submits to the State Medicines Control Agency an application to revoke the licence ; 2) the licence holder whose licence has been suspended fails to eliminate the violations of the licensed activity terms within the established time period; 3) the State Medicines Control Agency establishes that upon suspension of the licence the legal person or its branch continues to engage in activity subject to licensing; 4) the legal person is dissolved; 5) if erroneous data has been submitted for the issuance of the licence; 6) upon suspending the licence, the licence holder committed an infringement within 12 months from the lifting of suspension of the licence which would lift suspension of his licence. 4. The State Medicines Control Agency shall suspend or revoke the licence for all or part of activities if the licence holder violates the requirements of this Law, of the Rules of Licensing of Pharmaceutical Activity or those established by the Minister of Health. 5. If a criminal or administrative action is instituted for the violations of pharmaceutical activity committed by a qualified person employed for the performance of duties under Article 29 of this Law, whose qualification and experience satisfies the requirements of Article 28 of this Law (hereinafter – the qualified person responsible for the manufacture and/or import) or by the pharmaceutical activity manager or lf investigation of violations of labour regulations is started, the State Medicines Control Agency shall suspend his powers for the period of the proceedings or investigation. CHAPTER VI MANUFACTURE AND IMPORT FROM THIRD COUNTRIES Article 24. Principal Requirements for Manufacture and Import from Third Countries 1. 1. A legal person may engage in manufacture and/or import from third countries of medicinal product, investigational medicinal products only having received a manufacturing licence issued according to the procedure established by law. 2. 2. A legal person may engage in total and partial manufacture of medicinal products, investigational medicinal products and/or in the various processes of dividing up, packaging or presentation only subject to holding of an authorisation. He must also acquire the authorisation when manufacture and/or import of medicinal products, investigational medicinal products intended for export. A manufacturing licence shall grant the right to distribute the medicinal products manufactured by the licence holder 3. 3. The manufacturing licence shall not be required for: 1) manufacturing extemporaneous medicinal products; 2) for repackaging or changing the presentation of the medicinal products manufactured industrially or by a method involving an industrial process if the activity is performed by pharmacies or branches and the medicinal products are intended only for the natural persons provided services by the pharmacy or the pharmacy branch. 3) radiopharmaceutical products manufactured in accordance with the manufacturer’s instructions from authorised radionuclide generators, radionuclide kits or radionuclide precursors prior to their use in the health care establishment holding a licence to work with the sources of ionising radiation. 4) if the investigational medicinal product requires reconstitution before administration or packaging where this is carried out in clinical trials centres by pharmaceutical specialists or other persons authorised for the purpose and these products are intended for use in the centre only; 5) import of bearer prescription medicinal products from third countries 4. 4. Medicinal products, investigational medicinal products manufactured and/or imported from third countries in accordance with the principles and guidelines of good manufacturing practice for medicinal products and investigational medicinal products, approved by the Minister of Health and taking into account the recommendations of the European Commission, the European Medicines Agency and other European Union institutions (hereinafter referred to as good manufacturing practice). 5. 5. Medicinal products, investigational medicinal products imported from third countries must be manufactured in enterprises authorised by an authorised institution of the country to engage in manufacturing medicinal products, investigational medicinal products and standards of good medicinal practice of which are at least. equivalent to those laid down in the Community. 6. Only those active substances which have been manufactured taking into account the EU Commission’s principles and recommendations for good manufacturing practice of starting materials may be used as starting materials in the manufacture of medicinal The provision shall also be applicable with respect to the excipients the list and specific conditions of use whereof is established by the European Commission (hereinafter - the excipients entered in the list of the European Commission). 7. Total and partial manufacture as well as import of an active substance and the various processes relating to its dividing up, packaging, labelling and presentation prior to its use in manufacturing medicinal product, including its cardboard packaging and labelling, shall be assigned to the manufacture of active substances used as starting materials for the manufacture of medicinal products. 8. The provisions of this Chapter shall also be applicable with respect to intermediate products. 9. Blood products may be manufactured only from human blood and plasma selected and tested according to the requirements prescribed by the Minister of Health. The Law shall be supplemented with Article 241 from 1 July 2009; paragraph 4 of the Law shall enter into force on 30 December 2008 Article 241. Requirements for the Manufacture of Medicinal Products of Progressive Therapy for Specific Patients 1. The right to manufacture under doctor’s assignment for specific patients medicinal products of progressive therapy shall rest with legal persons having the licence for individual health care protection and the permit issued by the State Medicines Control Service. 2. The Health Care Minister shall set the quality standards of such medicinal products, the security, traceability, requirements of pharmacovigilance in keeping with advanced therapy of medicinal products and the procedure for issuing permits for their production. 3. The medicinal products of advanced therapy for specific patients may be manufactured and used under doctor’s assignment only in the Republic of Lithuania after the doctor takes professional liability for their prescription and use. 4. Manufacturing medicinal products of progressive therapy utilising human embryo tissue, human embryonic stem cells and their lines or foetal tissue and stem cells taken from them or otherwise utilising human embryo tissue, human embryonic stem cells and their lines or foetal tissue and stem cells and their lines taken from them in the manufacture of such medicinal products shall be prohibited. This prohibition shall not apply to the production of medicinal products of progressive therapy from stem cells derived from the cord or placenta after childbirth. Law No XI-59 shall come into force after the passage of 6 months following its publication in “Valstybės žinios” (the official gazette). The Minister of Health shall draft and approve by 1 July 2009 the legal acts required for implementing the provisions of paragraph 2 of Article 241 set out in Article 3 of Law No XI-59. Article 25. Requirements for a Legal Person Wishing to Obtain the Manufacturing Licence A legal person wishing to obtain the manufacturing licence must: 1) specify in the application the medicinal products and pharmaceutical forms which are to be manufactured or imported , groups and pharmaceutical forms of investigational medicinal products and also the place where they are to be manufactured and/or controlled. 2) have at his disposal, for the manufacture or import of the specified medicinal products, investigational medicinal products, suitable and sufficient premises, technical equipment and control facilities complying with the legal requirements laid down in this Law, the Rules of Licensing of Pharmaceutical activity, and the product manufacture, control and storage requirements laid down by the Minister of Health, ensure the application of methods of manufacturing and investigation specified in the documents submitted for the issuance of manufacturing authorisation; 3) enter into a contract of employment with a person for fulfilling the duties of a qualified person responsible for the manufacture and/or import; 4) comply with other requirements laid down in this Law, the Rules of Licensing of Pharmaceutical activity and the Minister of Health. Article 26. Principles of Issuing Manufacturing Licence 1. 1) The manufacturing licence shall be issued for engaging in activities only in the premises specified in the application and with the medicinal products or their groups and pharmaceutical forms specified in the application. The duties of the qualified person responsible for manufacture and/or import may be fulfilled only by the person who is recorded in the licence. 2. 2. The manufacturing licence shall be issued or a justified decision to refuse issuing it shall be adopted within 90 days from the day of receipt of the application submitted according to the established requirements. 3. If the licence holder asks to record the changed information and data in the documents submitted for obtaining the licence, the decision or a justified refusal to record them shall be taken not later than within 30 days from the day of receipt of the application submitted according to the established requirements. The time limit may be extended up to 90 days by a justified decision of the State Medicines Control Agency Article 27. Main Duties of the Manufacturing Licence Holder The manufacturing licence holder must: 1) employ a sufficient number of adequately qualified personnel for the performance of pharmaceutical activity according to the established requirements; 2) perform activities with investigational medicinal products and/or medicinal products, in respect of which a marketing authorisation has been granted, in the If EEA state only according to the legal acts of the state; 3) notify the State Medicines Control Agency in advance of all the changes in the information or data he would like to make in the documents submitted for obtaining the licence; 4) forthwith notify the State Medicines Control Agency of the changing of the qualified person responsible for manufacture and/or import; If the qualified person specified in the licence who is responsible for manufacture and/or import cannot carry out his duties due to illness, vacation or for other objective reasons, his functions may be entrusted only to another qualified person responsible for manufacture and/or import. In this case the manufacturing licence holder must designate or employ another qualified person responsible for manufacture and/or import and forthwith notify the State Medicines Control Agency thereof. If another qualified person responsible for manufacture and/or import is employed for a period not exceeding 3 months per year, the licence need not be varied; 5) allow the employees of the State Medicines Control Agency, holding the powers of administration over persons subordinate and not subordinate according to their duties, upon presenting their certificate of employment and order, to freely and without a prior notice enter during the working hours of the manufacturing licence holder and at other time, with the assistance of officials representing the competent authority, enter all premises of activity specified in the licence in order to check compliance with the requirements of this Law and other regulatory enactments; to submit data and documents (their copies, transcripts), articles necessary to perform the functions of the State Medicines Control Agency; 6) confer on the qualified person responsible for manufacture and/or import powers to fulfil the duties prescribed to him by this Law and ensure their continuous and uninterrupted performance; 7) adhere to good manufacturing practice; 8) use as starting materials only those active substances which satisfy the requirements of paragraph 6 of Article 24 of this Law; 9) distribute medicinal products of own manufacture or imported medicinal products in compliance with all requirements binding on wholesale distribution licence holder. 10) have a plan for the recall from the market of medicines and notify the State Medicines Control Agency of the started and completed implementation of recall from the market of medicinal products and submit all relating information; 11) comply with other requirements laid down by legal acts. Article 28. Qualification Requirements of a Qualified Person Responsible for Manufacture and Import Qualification and experience requirements of a qualified person responsible for manufacture and/or import. If batches Article 29. Main Duties of a Qualified Person Responsible for Manufacture and Import 1. The qualified person responsible for manufacture and/or import must fulfil the duties established in this Law, other legal acts and administrative acts of a licence holder He shall be responsible for the following: 1) that each batch of medicinal products has been manufactured and checked in accordance with the requirements of this Law and other legal acts and is in accordance with the documents submitted for obtaining the marketing authorisation; 2) in the case of medicinal products coming from third countries, that each production batch has undergone in Lithuania or any other EEA state a full qualitative analysis, a quantitative analysis of at least all the active constituents and all the other checks or tests necessary to ensure the quality of medicinal products in accordance with the documents submitted for obtaining the marketing authorisation; 3) that each batch of the medicinal product under investigation has been manufactured and checked according to good manufacturing practice, the product specification dossier and the sponsor’s documents submitted when requesting an authorisation to conduct a clinical trial; 4) that each batch of the medicinal product under investigation imported from a third country has been manufactured and checked applying standards of good manufacturing practice at least equivalent to those laid down by the Community, the product specification dossier and that controls have been carried out of each batch of medicinal product according to the documents submitted when requesting an authorisation to conduct a clinical trial; 5) if the medicinal product under investigation is a reference product from a third country which has been granted marketing authorisation but there is no possibility to obtain documents confirming that each batch of the product has been manufactured applying standards of good manufacturing practice at least equivalent to those laid down by the Community, that all analysis, all the other tests or checks necessary to ensure the quality of the medicinal product in accordance with the documents submitted applying for the authorisation to carry out clinical trial. 2. If batches of medicinal products have undergone controls provided for in paragraph 1 of this Article in another EEA state, they shall be exempt from repeated controls if the batches are supplied to the market accompanied by the quality control documents signed by a qualified person of the state who is responsible for manufacture and/or import. 3. 3. In case of medicinal product imported from a country with which the European Community has signed a mutual recognition agreement to ensure that the manufacturer applies standards of good manufacturing practice at least equivalent to those laid down by the Community and that the controls referred to under subparagraph 2 of paragraph 1 of this Article have been carried out in the exporting country, the qualified person responsible for manufacturing and/or import may be relieved of responsibility for carrying out those controls. 4. 4. In all cases the qualified person responsible for manufacturing and/or import must certify in a register of registering batches of medicinal products, investigational medicinal products or in the documents provided for that purpose that each production batch satisfies the requirements set this Article and other legal acts. This register or equivalent document must be kept up to date as operations of manufacture and/or import from third countries are carried out and must be placed upon request at the disposal of the State Medicines Control Agency. The filled in register or the equivalent document used for registering the batches of medicinal products must be kept for the period of 5 years. CHAPTER vii WHOLESALE DISTRIBUTION Article 30. Main Requirements of Wholesale Distribution 1. A legal person shall have the right to engage in wholesale distribution of medicinal products, active substances and excipients in the list of the European Commission, used in manufacturing of medicinal products or extemporaneous medicinal products, only holding a wholesale distribution licence issued according to the procedure established by this Law. 2. Wholesale distribution shall be performed in compliance with the requirements of this Law, good distribution practice regulations approved by the Minister of Health and with a view to the recommendations of the European Commission, the European Medicines Agency and other EU institutions (hereinafter referred to as Good Distribution ). 3. If the holder of the wholesale distribution licence wishes to engage in the manufacture and/or import of medicinal products from third countries, he must acquire the manufacturing licence. 4. Requirements more stringent than those applied to legal persons holding a wholesale distribution licence issued according to the procedure established by this Law may not be applied with respect to persons holding a wholesale distribution licence issued by other EEA states and wishing to engage in wholesale distribution in the Republic of Lithuania. Article 31. Requirements for a Legal Person Wishing to be Issued a Wholesale Distribution Licence A legal person wishing to be issued a wholesale distribution licence must: 1) specify in the application groups of medicinal products distribution whereof is intended (according to the temperature regime and groups established by the Minister of Health), indicate whether or not active substances, excipients entered in the list of the European Commission which are used for the manufacture of medicinal products or extemporaneous medicinal products will be distributed; 2) taking into account the recommendations of the European Commission, the European Medicines Agency and other EU institutions, have suitable adequate premises and equipment so as to ensure proper conservation under the conditions laid by the manufacturer and distribution of the medicinal products; 3) conclude a contract of employment with the person whose qualification would meet the requirements set in Article 34 of this Law for carrying out the duties of the manager of the pharmaceutical activities; 4) comply with other requirements laid down in this Law, the Rules of Licensing of Pharmaceutical activity and the Minister of Health. 5) undertake to fulfil the obligations incumbent on them under Article 33 of this Law. Article 32. Issue of a Wholesale Distribution Licence 1. A wholesale distribution licence shall be issued for engaging in the activities only in the premises indicated in the legal person’s application and only with the groups of products specified in the application. The duties of the manager of pharmaceutical activity may be carried out only by the person recorded in the licence. 2. The wholesale distribution licence shall be issued or a justified decision to refuse issuing it shall be adopted within 90 days from the day of receipt of the application submitted according to the established requirements. 3. If the licence holder asks to record the changed licence information and data, the decision to satisfy the request or a justified refusal shall be taken not later than within 30 days from the day of receipt of the application submitted according to the established requirements. The time limit may be extended up to 90 days by a justified decision of the State Medicines Control Agency. Article 33. Main Duties of the Wholesale Distribution Licence Holder The wholesale distribution licence holder must: 1) employ a sufficient number of adequately qualified personnel for the performance of t pharmaceutical activity according to the established requirements; 2) allow the employees of the State Medicines Control Agency, holding the powers of administration over persons subordinate and not subordinate according to their duties, upon presenting their certificate of employment and order, to freely and without a prior notice enter during the working hours of the wholesale distribution licence holder and at other time, with the assistance of officials representing the competent law enforcement authority, enter all premises of activity specified in the licence in order to check compliance with the requirements of this Law and other regulatory enactments; to submit data and documents (their copies, transcripts), articles necessary to perform the functions of the State Medicines Control Agency; 3) submit to the State Medicines Control Agency information on the distribution of medicinal products being performed and intended and the introduced material changes which may affect the quality, safety and efficacy of the medicinal product; 4) obtain (in the cases established by legal acts - import) medicinal products only from legal persons in possession of the manufacturing or wholesale distribution licence; 5) distribute only those medicinal products or their groups which are stored in the premises which correspond to the storage conditions specified in the licence and licence documents; 6) supply to the market of the Republic of Lithuania only registered medicinal products and, in the cases specified in this Law, unregistered medicinal products; 7) supply medicinal products only to persons who are in possession of the wholesale distribution, pharmaceutical activity and/or health care activities licence; 8) cooperating with marketing authorisation holders ensure availability and frequent supply of medicinal products to pharmacies and personal health care establishments; 9) have an emergency plan which ensures effective implementation of any recall from the market ordered by the State Medicines Control Agency or to implement it in cooperation with the manufacturer or marketing authorisation holder for the medicinal product concerned ; 10) keep records giving for any transaction in medicinal products received or dispatched the following information: date, name of medicinal product, batch of the medicinal product, quantity of the medicinal product received or sold, name and address of the supplier or consignee; 11) supply medicinal products only with the following documents enclosed: the date, the name and pharmaceutical form of the medicinal product, the quantity supplied; the name and address of the supplier and consignor. 12) preserve for 5 years according to the procedure established by the Government of the Republic of Lithuania the documents specified in subparagraph 10 of this Article and when necessary submit them at the request of the State Medicines Control Agency; 13) carry out pharmaceutical activity according to the requirements of good distribution practice; 14) distribute only those active substances and excipients entered in the list of the European Commission which have been manufactured according to the principles and recommendations of good manufacturing practice of the European Commission; 15) designate persons responsible for pharmaceutical activity and ensure the required number and qualification of specialists performing and controlling pharmaceutical activity: 16) confer on the pharmaceutical activity manager sufficient powers to carry out the duties delegated to him and to ensure permanent and continuous performance of functions assigned to him; 17) notify the State Medicines Control Agency if the pharmaceutical activity manager is changed. If the pharmaceutical activity manager specified in the licence is unable to perform his duties due to illness, vacation or other objective reasons, his functions may be delegated only to another person who satisfies the requirements posed to pharmaceutical activity manager, referred to in Article 34 of this Law. If the pharmaceutical activity manager is replaced for a period exceeding one month, the wholesale distribution licence holder must notify the State Medicines Control Agency. If the pharmaceutical activity manager is replaced for a period not exceeding 3 months per one year, licence information and data need not be varied. 18) fulfil the requirements set by other legal acts. Article 34. Qualification and Experience Requirements and Main Duties of the Pharmaceutical activity Manager Responsible for Wholesale Distribution 1. The pharmacist holding a licence for pharmaceutical activity and having a two-year work experience acquired at a wholesale distribution enterprise within last 10 years may be the pharmaceutical activity manager responsible for wholesale distribution. 2. The pharmaceutical activity manager must fulfil the duties set out in this Law, other legal acts and administrative acts of the licence holder. He shall be responsible that: 1) the pharmaceutical activity be carried out according to good distribution practice of medicinal products:2 2) heads of the legal person be informed on whether the activities comply with the requirements set by this Law and other legal acts; 3) only the medicinal products, active substances satisfying the requirements set by this Law and other legal acts and the excipients entered in the list of the European Commission be distributed; 4) customers’ complaints or notices about the quality of the medicinal product, active substance and the excipient entered in the list of the European Commission and/or services be responded to; 5) the system of withdrawal from the market of the medicinal products, active substances be introduced and functioned adequately. CHAPTER VIII ACTIVITIES OF PHARMACIES Article 35. Types of Pharmacies and Peculiarities of Pharmacy Activities 1. Pharmacies and their branches shall be et up according to the procedure established by the Minister of Health. A legal person shall have the right to engage in pharmacy activities only being in possession of a production pharmacy licence issued according to the procedure established by this Law and to manufacture extemporaneous medicinal products only being in possession of a production pharmacy licence. 2. Pharmacies shall be divided according to the type of activity into: community pharmacies, production community pharmacies, hospital pharmacies, production hospital pharmacies, university pharmacies and charity pharmacies. 3. A community pharmacy shall be a pharmacy in which medicinal products are kept, controlled and sold (dispensed) to the residents and legal persons who do not possess a licence for the provision of personal health care services or a licence for pharmaceutical activity, the binding commitments of the Minister of Health in supplying the residents with medicinal products are fulfilled and student teaching practice and vocational practice is conducted. 4. Production community pharmacy means a community pharmacy which manufactures extemporaneous medicinal products and sells/dispenses medicinal products to the residents and may sell/dispense medicinal products prepared in a pharmacy according to the Magistral Formula to a legal person in possession of a licence for the provision of personal health care services. A production pharmacy may sell/dispense via its branches Magistral Formula medicinal products manufactured by it according to the procedure established by the Minister of Health. 5. A hospital pharmacy, production hospital pharmacy shall be a subdivision of a health care establishment which supplies the hospital with medicinal products but is not entitled to sell/dispense them to the patients undergoing outpatient treatment. 6. A university pharmacy shall be a structural subdivision of a university which trains specialists in pharmacy and fulfils the functions of a community or production c