4.A pharmacy shall have the right to repackage or change the presentation of the medicinal products manufactured industrially or by a method involving an industrial process as indicated in subparagraph 2 of paragraph 3 of Article 24.
\n
5.Extemporaneous medicinal products and medicinal products which have been repackaged according to the provisions of paragraph 4 of this Article may be sold /dispensed only to the residents directly serviced by the pharmacy or branch and Magistral Formula medicinal products – also to legal persons in possession of a licence for the provision of personal health care services. It shall be prohibited to dispense/sell them to another pharmacy or its branch.
\n
6.According to prescriptions presented to the production pharmacy the Magistral Formula medicinal products may be dispensed to legal persons holding a licence for the provision of personal health care services.
\n
7.Actions specified in paragraphs 1, 4 and 5 of this Law shall be carried out according to the procedure established by the Minister of Health.
\n
Article 37Requirements for Obtaining a Licence for Pharmaceutical Activity
\n
A legal person wishing to obtain a licence for pharmacy activities must:
\n
1)have at his disposal suitable premises and technical equipment complying with the requirements laid down by the Minister of Health;
\n
2)enter into a contract of employment for fulfilling the duties of a pharmaceutical activity manager;
\n
3)comply with other requirements laid down in this Law, the Rules of Licensing of Pharmaceutical Activity and other legal acts.
\n
Article 38Issuing a Licence for Pharmacy Activities
\n
1.Pharmacy activities licence shall be issued only for performing a specified type of activities and only in the premises specified in the legal person’s application. The pharmacy activities licence shall apply only to the same premises or at the same address, with the exception of health care establishments.
\n
2.2. The pharmacy activities licence shall be issued or a justified decision to refuse issuing it shall be adopted within 45 days from the day of receipt of the application submitted according to the established requirements. If the licence holder requests to change the conditions of activities specified in the licence, the time taken for the procedure relating to satisfying the request or the adoption of a justified decision to refuse the changing shall be not longer than 30 days.
\n
Article 39Duties of the Pharmacy Activities Licence Holder
\n
The pharmacy activities licence holder must:
\n
1)employ a pharmaceutical activity manager and confer on him sufficient powers enabling him to perform the duties entrusted to him.
\n
2)obtain medicinal products, active and other medicinal substances only from the legal persons holding the manufacturing or wholesale distribution licence;
\n
3)ensure the storage of medicinal products in the conditions indicated by the manufacturer;
\n
4)adequately and expeditiously participate in withdrawing medicinal products from the market, collect from the residents medicinal products subject to destruction;
\n
5)carry out the activities according to Good Pharmacy Practice regulations;
\n
6)take part in implementing the system of pharmacovigilance;
\n
7)keep and manage the documents of acquisition and transfer, in which the licence holder must indicate, besides the mandatory particulars, the following information: the name of the medicinal product, pharmaceutical form, batch and quantity of the medicinal product;
\n
8)perform the activities only in non-residential premises according to the procedure established in this Law and by the Minister of Health.
\n
Article 40Qualification Requirements and Main Duties of the Pharmacy Pharmaceutical activity Manager
\n
1.Only a pharmacist holding a pharmaceutical activity licence may be a pharmaceutical activity manager.
\n
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:
\n
1)pharmaceutical activity be carried out according to the requirements established by this Law and other legal acts;
\n
2)the pharmacy would acquire, keep and sell/dispense only registered medicinal products as well as medicinal products which are permitted to be used for health care by other legal acts;
\n
3)the complaints or notices about the quality of the medicinal product and/or pharmacy services received from the medicinal product users be adequately and expeditiously responded to;
\n
4)withdrawing of medicinal products from the market and collecting from the residents of medicinal products which are to be destroyed or are unwanted be adequately and expeditiously participated in;
\n
5)provision of pharmacy service be ensured, proposals to heads of administration concerning the improvement of qualifications of pharmacists and pharmacist’s assistants (pharmacy technicians) be presented;
\n
6)control of production of extemporaneous medicinal products be ensured.
\n
Article 41Supply of Rural Residents with Medicines
\n
1.Pharmacies and their branches shall be set up and function in rural localities according to the procedure established by the Minister of Health. The State and municipality may apply tax and fee reliefs, provide assistance and otherwise support pharmacies located in rural localities 2. In rural localities, where there is no pharmacy or pharmacy branch, the residents shall be supplied with medicinal products via the primary health care establishments located in rural localities according to the procedure established by the Government by the pharmacies which have concluded contracts for the provision of medicinal products with the primary health care establishments.
\n
CHAPTER NINE PHARMACEUTICAL WASTE MANAGEMENT
\n
Article 42Collection of Pharmaceutical Waste from the Residents
\n
1.Pharmaceutical waste shall be collected from the residents and pharmaceutical waste holders, managed and paid for according to the procedure established by the Government.
\n
2.The management of pharmaceutical waste collected from the residents shall be paid for from the State budget.
\n
Article 43Management of Pharmaceutical Waste and its Peculiarities
\n
1.A legal person shall have the right to manage pharmaceutical waste only being in possession of the licence for managing pharmaceutical waste, except for waste disposal, issued according to the procedure established by this Law.
\n
2.The requirement set in paragraph 1 of this Article shall not be applied with respect to legal persons collecting pharmaceutical waste from the residents.
\n
Article 44Requirements for Obtaining a Licence for Pharmaceutical Waste Management, except for its Disposal
\n
A legal person, wishing to obtain a licence for pharmaceutical waste management, except for its disposal, must:
\n
1)have at its disposal suitable premises, technical equipment which would comply with the requirements laid down by the Minister of Health and ensure proper storage and management of pharmaceutical waste;
\n
2)enter into a contract of employment for fulfilling the duties of a pharmaceutical activity manager;
\n
3)according to the requirements of the Law on Waste Management, be in possession of the authorisation issued following the procedure laid down by the Ministry of Environment;
\n
4)comply with the requirements of this Law, the Rules of Licensing of Pharmaceutical Activity and the requirements laid down by the Minister of Health.
\n
Article 45Issuing of a Licence for Pharmaceutical Waste Management, except for its Disposal
\n
1.The State Medicines Control Agency shall issue a licence for the management of pharmaceutical waste, except for its disposal, only having ascertained that the submitted data and information meet the requirements set in this Law and by Minister of Health.
\n
2.A licence for pharmaceutical waste management, except for its disposal, shall be issued for engaging in the activities only in the premises specified the legal person’s application.
\n
3.A licence for pharmaceutical waste management, except for its disposal, shall be issued or a justified decision to refuse issuing it shall be adopted within 60 days from the day of receipt of the application submitted according to the established requirements. If the licence holder requests to change the information and conditions specified in the licence, the time taken for the procedure relating to this request or for adopting a justified decision of refusal shall not exceed 30 days.
\n
Article 46Duties of the Holder of a Licence for Pharmaceutical Waste Management, except for its Disposal
\n
The holder of a licence for pharmaceutical waste management, except for its disposal, must:
\n
1)ensure that pharmaceutical waste should be managed according to the technical regulation defining in detail the process of waste collection, sorting, storage, entry into records. The technical regulation agreed with the Ministry of Environment shall be approved by the Director of the Department of Pharmacy under the Ministry of Health;
\n
2)employ a pharmaceutical activity manager and confer on him sufficient powers enabling him to perform the duties entrusted to him;
\n
3)ensure that the premises of pharmaceutical waste management, except for its disposal, meet the requirements of legal acts and licence information and data.
\n
Article 47Qualification Requirements and Main Duties of the Pharmaceutical activity Manager of the Enterprise for Waste Management, except for Disposal
\n
1.Only a pharmacist holding a pharmaceutical activity licence may be a pharmaceutical activity manager of an enterprise for waste management, except for disposal.
\n
2.The enterprise 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:
\n
1)pharmaceutical waste is managed according to the requirements established by this Law and other legal acts;
\n
2)pharmaceutical waste is expeditiously collected;
\n
3)pharmaceutical waste, according to the established requirements, is sorted, divided up, packaged, labelled;
\n
4)safe storage and transportation of pharmaceutical waste is ensured;
\n
5)accounting of pharmaceutical waste is properly carried out.
\n
CHAPTER TEN INFORMATION ABOUT MEDICINAL PRODUCTS
\n
Article 48Pharmaceutical Information
\n
1.The pharmaceutical information about medicinal products must be scientifically justified, objective, not misleading and not hazardous to human health.
\n
2.The pharmaceutical information about the registered medicinal products must be in keeping with the summary of the medicinal product characteristics.
\n
3.The pharmaceutical information about unregistered medicinal products must be submitted accompanied by a notice that this is an unregistered medicinal product.
\n
4.The pharmaceutical information comparing several medicinal products, of which at least one is subject to medical prescription, may be presented only to health care professionals and pharmaceutical specialists.
\n
5.When the pharmaceutical information about medicinal products is provided on the radio, television and in publications, only the common name of medicinal products may be used, except in cases where the pharmaceutical information is prepared and announced meeting the requirements set in paragraphs 5 and 7 of Article 66 and Article 67.
\n
6.The provisions of paragraph 5 of this Article shall not be applied to the names of medicinal products indicated in scientific articles which are published in the publications overviewed by the Institute of Scientific Information and in other recognised international data bases the list whereof shall be drawn up by the Lithuanian Scientific Council, in monographs, textbooks, methodical and other scientific publications.
\n
7.Only persons who have completed appropriate biomedical science studies the list whereof shall be approved by the Minister of Health may prepare pharmaceutical information about the properties of medicinal products, except in cases where the information is prepared and published in compliance with the requirements set in paragraphs 5 and 7 of Article 66 and Article 67.
\n
8.The medicinal product marketing authorisation holder in at least one of the EEA states must set up a scientific service for accumulating information about the medicinal products supplied to the market.
\n
9.The right to disseminate pharmaceutical information shall be vested in the marketing authorisation holder and/or his representative, a person possessing a licence for pharmaceutical activity qualifying him to work with medicinal products issued according to the procedure established by this Law, a legal person possessing a licence for the provision of personal health care services.
\n
10.The pharmaceutical information about medicinal products publicised by the State Medicines Control Agency shall be considered official pharmaceutical information.
\n
Article 49General Provisions of Advertising of Medicinal Products
\n
1.Only registered medicinal products may be advertised in the Republic of Lithuania.
\n
2.The advertising of a medicinal product shall not be misleading and shall be objective, the information and the terms used therein shall comply with the particulars listed in the summary of product characteristics, present it objectively and without exaggerating its properties and encourage its rational use.
\n
3.All advertising to the general public of medicinal products shall be set in such a way that it is clear that the message is an advertisement and that the product is identified as a medicinal product.
\n
Marketing authorisation holders and/or their representatives must raise the qualification of medical sales representatives.
\n
5.The medicinal product marketing authorisation holder and one or more legal persons authorised by him may engage in common activities of medicinal product marketing stimulation (e.g.: sales promotion, application of advertising, formation of market and/or its conditions, etc) 6. Advertising of medicinal products subject to medical prescription through publications, in radio and television broadcasts and through other electronic media shall be prohibited, except in cases specified in paragraph 2 of Article 51 of this Law.
\n
7.The following institutions and persons shall have no right to advertise medicinal products:
\n
1)State and municipal institutions and their employees;
\n
2)health care and/or pharmaceutical specialists providing health care or pharmacy services 8. Other requirements relating to the advertising of medicinal products to the general public and health care, pharmaceutical specialists, the bringing in or import of free samples of medicinal products, their transfer to the marketing authorisation holder or his representative, the criteria of professional/scientific and advertising undertakings shall be established by the Minister of Health.
\n
Article 50Advertising of Medicinal Products to the General Public
\n
1.Advertising intended to the general public shall be of medicinal products which are available on medical prescription only presenting the information and references prescribed by the Minister of Health.
\n
2.It shall be prohibited to advertise to the general public:
\n
1)medicinal products which contain psychotropic and/or narcotic substances entered in lists of controlled narcotic and psychotropic substances approved by the Minister of Health;
\n
2)medicinal products which are subject to medical subscription except in cases where the manufacturers of the medicinal products, having obtained authorisation of the Minister of Health, carry out the vaccination campaign of the general public;
\n
3)medicinal products (irrespective of their strength or amount in the packaging) the names whereof are recorded in the price list of medicinal products subject to reimbursement approved by the Minister of Health.
\n
3.Only information specified in the package leaflet and on the packaging may be used advertising homeopathic products registered applying the simplified registration procedure and the references prescribed by the Minister of Health shall also be presented.
\n
4.It shall be prohibited in the advertising to the general public:
\n
1)to refer to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of the medicinal product;
\n
2)to present a detailed description or representation of a case history which could lead to erroneous self-diagnosis;
\n
3)to refer, in improper, alarming or misleading terms, to claims of recovery;
\n
4)to use misleading terms or improper pictorial representation of changes in the human or animal body caused by disease or injury, or of the action of the advertised medicinal product
\n
5)to present material directed exclusively or principally at children;
\n
6)to give an impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail and by other information media;
\n
7)to suggest that the effects of taking the medicine are guaranteed and are unaccompanied by adverse reactions;
\n
8)to suggest that the effects of the advertised medicinal product are better than or equivalent to those of another medicinal product or treatment;
\n
9)to suggest that the health of the subject can be enhanced by taking the advertised medicinal product;
\n
10)to suggest that the health of the subject could be affected by not taking the medicinal product; this provision shall not apply to carrying out the vaccination campaigns;
\n
11)to suggest that the medicinal product is a foodstuffs, cosmetic or other consumer product;
\n
12)suggest that the safety or efficacy of the medicinal product is due to the fact that is natural;
\n
13)to influence residents through persistent offers of medicinal products, indicating the alleged price reductions on price lists, price labels, pharmacy premises, other means or measures contrary to good morals and public order.
\n
5.It shall be prohibited to directly distribute to the public medicinal products for promotional purposes.
\n
6.It shall be prohibited to suggest, when selling (dispensing) medicinal products not subject to medical prescription, to additionally purchase analgesic medicinal products.
\n
Article 51Advertising of medicinal Products to Health Care Professionals and Pharmaceutical specialists
\n
1.Advertising to health care pharmaceutical specialists of prescription and non-prescription medicinal products shall be permitted.
\n
2.Medicinal products subject to medical prescription may be advertised only in publications intended to health care professionals and pharmaceutical specialists. The list of such publications and the criteria of inclusion in the list shall be approved by the Minister of Health.
\n
3.Any advertising intended for health care professionals and pharmaceutical specialists shall include information about the medicinal product specified by the Minister of health.
\n
4.Advertising medicinal products to health care professionals qualified to prescribe such medicinal products the advertisers may use the free samples of medicinal products. A free sample of medicinal product not for sale shall be identical with the smallest presentation on the market of the medicinal product of the same name, form and strength and each packaging shall be marked “free medical sample not for sale.” It shall be prohibited to leave fee samples of medicinal products with the health care professionals, distribute them among the pharmaceutical specialists and the general public and use them for health care purposes.
\n
5.The provision of inducements to health care professionals and pharmaceutical specialists to prescribe, supply or sell/dispense medicinal products by giving remuneration whether in money or in kind shall be prohibited and the above specialists shall be prohibited from asking or accepting the remuneration.
\n
6.Hospitality at professional/scientific sales promotion of medicinal products shall always be reasonable in level and must not be extended to other than the participating health care professionals and/or pharmaceutical specialists. Payment of travelling, accommodation and other expenses of the above professionals and specialists shall be prohibited.
\n
7.Hospitality at professional/scientific congresses shall be secondary to the main purpose of the meeting. Only the payment of travelling, accommodation, catering and/or registration expenses of health care professionals and/or pharmaceutical specialists shall be authorised.
\n
8.The marketing authorisation holder or his representative in the Republic of Lithuania must accumulate information about the expenses intended fir promotional, professional/scientific events and the health care professionals and/or pharmaceutical specialists participating therein and submit the information to the State Medicines Control Agency according to the procedure established by the Minister of Health.
\n
CHAPTER ELEVEN PHARMACOVIGILANCE
\n
Article 52General Requirements of Pharmacovigilance
\n
1.Pharmacovigilance shall be implemented in compliance with this Law, the procedure established by the Minister of Health and the recommendations of the European Commission concerning the rules governing medicinal products in the European Community. Implementing pharmacovigilance information on misuse and abuse of medicinal products shall also be taken into account as this may have an impact on the evaluation of benefits and risks of medicinal products.
\n
2.The Minister of Health must apply measures encouraging health care professionals and pharmaceutical specialists to provide information about the observed suspected adverse reactions.
\n
3.The implementation of pharmacovigilance shall be coordinated and the received pharmacovigilance information shall be managed by the State Medicines Control Agency.
\n
4.Health care professionals and pharmaceutical specialists must notify the State Medicines Control Agency according to the procedure established by the Minister of Health about the serious effects of adverse reaction or unexpected adverse reactions and other cases which could affect the state of health of the patients undergoing treatment, even if the medicinal product was administered not as specified in the summary of product characteristics or abused.
\n
5.Having received a notification of the suspected serious effect of adverse reaction determined in the Republic of Lithuania, the State Medicines Control Agency shall forthwith (not later than within 15 days of the receipt of the information) notify the European Medicines Agency, other EEA states and the holder of the medicinal product marketing authorisation through the Eudra Vigilance post-authorisation module of handling of notification in the EEA according to the procedure established by the State Medicines Control Agency.
\n
Article 53Duties of Marketing Authorisation Holder in Implementing Pharmacovigilance
\n
The medicinal product marketing authorisation holder must:
\n
1)establish measures of pharmacovigilance and implement them with respect to medicinal products the marketing authorisation whereof it possesses as well as guarantee that where necessary it will take appropriate measures agreed with the State Medicines Control Agency;
\n
2)permanently and continuously have at his disposal in at least one EEA state an appropriately qualified person responsible for pharmacovigilance and ensure fulfilment of the duties laid down in Article 54 of this Law; The information about the qualified person must be submitted to the State Medicines Control Agency;
\n
3)register suspected adverse reactions and submit periodical safety update reports according to the procedure established by the State Medicines Control Agency;
\n
4)in reporting serious adverse reactions internationally recognised medical terminology shall be used.
\n
Article 54Qualification and Responsibility of the Qualified Person Responsible for Pharmacovigilance
\n
1.A person possessing the doctor’s or pharmacist’s qualification and knowledge of pharmacovigilance may be the qualified person responsible for pharmacovigilance.
\n
2.The marketing authorisation holder shall create conditions for the qualified person responsible for pharmacovigilance to perform the functions assigned to him and obligate him:
\n
1)to be responsible for the establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the employees of the marketing authorisation holder, including medical representatives, is collected and collated in order to be accessible at least within one point of the Community;
\n
2)to prepare and submit to the State Medicines Control Agency periodic safety update reports;
\n
3)to ensure that any request by the State Medicines Control Agency for the submission of additional information necessary for the evaluation of benefit and risks afforded by the medicinal product be responded to properly and quickly, including the information on the amount of the medicinal product sold or prescribed;
\n
4)to be responsible for the submission to the State Medicines Control Agency of other information necessary for the evaluation of benefit and risks afforded by the medicinal product, including the information about the post-authorisation safety study.
\n
Article 55Registration of Adverse Reactions and Submission of Period Safety Update Reports
\n
1.The medicinal product marketing authorisation holder must:
\n
1)register all suspected adverse reactions occurring either in the Community or in a third country and report thereof to the State Medicines Control Agency and the European Medicines Agency. Reports shall be submitted electronically. In exceptional cases notice may also be given in other ways.
\n
2)register all suspected effects of adverse reactions which have been observed in the Republic of Lithuania and of which he has been informed by the health care professional or pharmaceutical specialist and forthwith (in any case within 15 days of the receipt of the information) notify the State Medicines Control Agency thereof;
\n
3)register all other suspected effects of adverse reactions observed in the Republic of Lithuania, which satisfy the criteria laid by the Minister of Health and of which he can be reasonably expected to have knowledge and immediately (within 15 days of receipt of information) report to the State Medicines Control Agency thereof;
\n
4)immediately (no later than 15 days following the receipt of information) notify the State Medicines Control Agency and the European Medicines Agency of all suspected serious unexpected effects of adverse reactions and the suspected transmission of agents of infection via a medicinal product observed in third countries.
\n
2.If mutual recognition procedure, decentralised procedure or procedure of arbitration by European Commission has been applied with respect to a medicinal product, the marketing authorisation holder must additionally ensure that all suspected serious effects of adverse reactions observed in the Community are notified to the reference state or the institution authorised by the member state which acts in the capacity of the reference state. The reference member state shall be responsible for the analysis and monitoring of such reactions.
\n
3.Unless other requirements have been laid down for registering the medicinal product, the marketing authorisation holder shall report to the State Medicines Control Agency all the adverse reactions in the format of periodic safety update report. The periodic safety update reports shall include a scientific evaluation of the benefit and risk afforded by the medicinal products.
\n
4.The periodic safety update reports shall be submitted six monthly after the day of granting the marketing authorisation until the supply of the product to the market, six monthly for two years after the first supply of the product to the market, annually for the subsequent two years and thereafter at three-yearly intervals. Moreover the reports shall be submitted immediacy at the request of the State Medicines Control Agency.
\n
5.The medicinal product marketing authorisation holder may request the State Medicines Control Agency to examine the terms of submitting periodic update reports in accordance with 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.
\n
6.The marketing authorisation holder may not provide information relating to pharmacovigilance to the general public without advance notification thereof of the State Medicines Control Agency. He must ensure that such information is objective and not misleading.
\n
Article 56
\n
Suspension or Revocation of Marketing Authorisation for a Medicinal Product or Making Variations to the Terms of Marketing Authorisation due to Pharmacovigilance Data 1. If the State Medicines Control Agency, upon assessing the pharamcovigilance data, believes that the marketing authorisation must be suspended or revoked or variations must be made to the terms of marketing authorisation it must forthwith notify thereof the European Medicines Agency, other EEA states and the medicinal product marketing authorisation holder.
\n
2.In case of necessity to take urgent measures to protect the health of the public the State Medicines Control Agency may suspend the marketing authorisation and not later than within one working day notify the European Medicines Agency, the European Commission and other EEA states thereof.
\n
Article 56
\n
Suspension or Revocation of Marketing Authorisation for a Medicinal Product or Making Variations to the Terms of Marketing Authorisation due to Pharmacovigilance Data 1. If the State Medicines Control Agency, upon assessing the pharamcovigilance data, believes that the marketing authorisation must be suspended or revoked or variations must be made to the terms of marketing authorisation, it must forthwith notify thereof the European Medicines Agency, other EEA states and the medicinal product marketing authorisation holder.
\n
2.In case of necessity to take urgent measures to protect the health of the public the State Medicines Control Agency may suspend the marketing authorisation and not later than within one working day notify the European Medicines Agency, the European Commission and other EEA states thereof.
\n
CHAPTER TWELVE PRICING OF REIMBURSABLE MEDICINAL PRODUCTS AND MEDICAL AID EQUIPMENT
\n
Article 57General Requirements of Pricing of Reimbursable Medicinal Products and Medical Aid Equipment
\n
1.The Minister of Health shall approve the base and highest wholesale prices of reimbursable medicinal products and medical aid equipment. Once per year they shall be published in the Reimbursable Medicinal Products Price List and Reimbursable Medical Aid Equipment Price List. When necessary the Minister of health shall supplement and/or adjust the price lists. All price lists and their supplements shall be published in “Valstybės žinios” and enter into force one month after their publication.
\n
2.The highest retail prices of reimbursable medicinal products and medical aid equipment shall be calculated by adding to the price declared by the holder of manufacturing authorisation of the medicinal product or his representative or the manufacturer of medicinal aid equipment or his representative the amount of wholesale or retail mark-ups laid down by the Minister of Health and the amount of value added tax if the medicinal product or the medical aid equipment is subject to the tax.
\n
3.Reimbursable medicinal products and reimbursable medical aid equipment shall be sold to the pharmacy and the legal person in possession of a licence for the provision of personal health care services at the price not exceeding the wholesale price which is calculated by adding to the price declared by the holder of the manufacturing authorisation of the medicinal product or his representative or the manufacturer of the medical aid equipment or his representative the retail mark-up laid down by the Minister of Health.
\n
4.The reimbursable medicinal products shall be sold to wholesale distribution licence holder and the reimbursable medical aid equipment shall be sold to the wholesale distribution enterprises at the price not exceeding the price declared to the competent state authorities by the manufacturing authorisation holder of the medicinal product or his representative or the manufacturer of the medical aid equipment or his representative.
\n
Article 58
\n
Entry of Medicinal Products in the Lists of Diseases and Reimbursable Medicinal Products for their Treatment, Reimbursable Medicinal Products and Reimbursable Medical Aid Equipment 1. Medicinal products, diseases and medical aid equipment shall be entered in the Lists of Diseases and Reimbursable Medicinal Products for their Treatment, Lists of Reimbursable Medicinal Products and Reimbursable Medical Aid Equipment according to the procedure established by the Minister of Health.
\n
2.Seeking to enter a medicinal product, a disease or medical aid equipment in the Lists specified paragraph 1 of this Article the applicant shall submit an application and documents to the Department of Pharmacy under the Ministry of Health according to the procedure established by the Minister of Health The applications shall be considered according to the procedure established by the Minister of Health.
\n
3.The decision concerning the entry of the medicinal product, disease or medical aid equipment in the Lists specified in paragraph 1 of this Article and their prices shall be adopted not later than within 180 days from the day of registration of the application with the Department of Pharmacy. If a decision is adopted the reasons of the decision based on objective and verifiable criteria shall be specified.
\n
Article 59Entry of Medicinal Products in the Price List of Reimbursable Medicinal Products and in the Price List of Reimbursable Medical Aid Equipment
\n
1.Approved shall be retail and base prices only of those reimbursable medicinal products the common name whereof has been entered in the Lists of Diseases and Reimbursable Medicinal Products for their Treatment and Lists of Reimbursable Medicinal Products approved by the Minister of Health, of medical aid equipment the name whereof has been entered in the List of Reimbursable Medical Aid Equipment and in respect whereof an application has been received for entering them in the Price List of Reimbursable Medicinal Products or in the Price List of Reimbursable Medical Aid Equipment.
\n
2.The application in the established form to enter the medicinal product or medical aid equipment in the Price List of Reimbursable Medicinal Products or Reimbursable Medical Aid Equipment shall be submitted to the Department of Pharmacy under the Ministry of Health according to the procedure established by the Minister of Health.
\n
3.Decisions on the establishment and/or increasing the price of reimbursable medicinal products shall be adopted not later than within 90 days from the day of receipt of the application submitted according to the requirements established by the Minister of Health. If the information submitted for the adoption of the decision is insufficient, the applicant shall be forthwith notified what additional information is required. The decision shall be adopted not later than within 90 days from the receipt of the information.
\n
4.In case a negative decision is adopted the applicant shall no later than within 14 days after the adoption of the decision be notified thereof in writing and the reasons of the decision based on objective and verifiable criteria shall be specified. If a decision on the determination and/or raising of the price is not adopted within the time period provided for in paragraph 3 of this Article the price of the medicinal product suggested by the applicant shall be entered in the subsequent Price List of Reimbursable Medicinal Products.
\n
CHAPTER XIII
\n
SUPPLY TO THE MARKET OF MEDICINAL PURPOSE PRODUCTS
\n
Article 60Peculiarities of Supply to the Market of Medicinal Purpose Products
\n
1.Only registered medicinal purpose products may be supplied to the market of the Republic of Lithuania 2. Medicinal purpose products shall be registered according to the procedure established by the Minister of Health entering them in the List of Medicinal Purpose Products and issuing the certificate of authorisation of the medicinal purpose product granting marketing authorisation in the Republic of Lithuania.
\n
3.The State Medicines Control Agency shall manage the List of Medicinal Purpose Products and issue marketing authorisation, renew the marketing authorisation of the medicinal purpose products, approve the variations in the terms of the marketing authorisation and suspend the marketing authorisation of products, lift the suspension of the marketing authorisation and/or revoke the marketing authorisation.
\n
4.The marketing authorisation certificate shall be issued or a justified refusal to issue the marketing authorisation certificate shall be adopted not later than within 90 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.
\n
5.The marketing authorisation certificate shall be issued for 6 years. An application for renewal of marketing authorisation of a medicinal purpose product must be submitted not later than 4 months before the expiry of validity of the marketing authorisation certificate. Upon renewal of marketing authorisation of a medicinal purposes product its marketing authorisation in the Republic of Lithuania shall be extended for 6 years.
\n
6.A State fee of the established amount shall be payable for the examination of the application for the issuance of marketing authorisation, renewal of authorisation of a medicinal purpose product and the accompanying documents and information as well as for the issuance of the marketing authorisation certificate.
\n
7.Only the legal persons entered in the List of Persons Performing Activities with Medicinal Purpose Products may manufacture medicinal purpose products, the List shall be managed by the State Medicines Control Agency. The procedure of entry in and removal from the List shall be established by the Minister of Health.
\n
8.Only the person holding a wholesale distribution licence may distribute and/or import from third countries medicinal purpose products and only the person holding a licence to engage in pharmacy activities may sell the products to the general public. In rural localities, where there is no pharmacy or pharmacy branch, the residents shall be supplied with medicinal purpose products according to the procedure established by the Government through primary health care institutions located in rural localities.
\n
9.The advertising of medicinal purpose product must be not misleading and objectively present its characteristics. The information and terminology must correspond to the terms of labelling and packaging leaflet approved by the State Medicines Control Agency. All advertising to the general public of a medicinal purpose product shall be set in such a way that it is clear that the message is an advertisement and that the product is identified as a medicinal purpose product .
\n
10.It shall be prohibited, when advertising medicinal purpose products, to:
\n
1)present information that the advertised product is a medicinal product or to indicate that the medicinal purpose product has a therapeutic effect, name the diseases or case history;
\n
2)suggest that the effects of the advertised medicinal purpose product are better than or equivalent to those of other medicinal purpose products, medicinal product or another treatment;
\n
3)suggest that the health of the subject could be affected by not taking the medicinal purpose product
\n
4)suggest that the safety or efficacy of the medicinal purpose product is due to the fact that it is natural;
\n
5)suggest that the health of the subject could be enhanced by taking the advertised medicinal purpose product ;
\n
6)use misleading terms or improper pictorial representation of changes in the human or animal body caused by disease or injury, or the advertised medicinal purpose product ;
\n
7)present material directed exclusively or principally at children;
\n
8)suggest that the effects of the medicinal purpose product are guaranteed and unaccompanied by adverse reactions;
\n
9)to refer to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of the medicinal purpose product;
\n
10)compare the medicinal purpose product to a medicinal product.
\n
11.The advertising of medicinal purpose products to state or municipal institutions shall be prohibited.
\n
12.Other requirements to activities related to medicinal purpose products shall be established by the Minister of health.
\n
CHAPTER XIV
\n
STATE CONTROL OF ACTIVITIES WITH PHARMACEUTICAL PRODUCTS
\n
Article 61Executive Body and Regulation of State Control of Activities with Pharmaceutical Products
\n
1.The State control of activities with pharmaceutical products prescribed by this Law shall be executed by the State Medicines Control Agency. State fee of the established amount shall be paid for the valuation, examination and issue of confirming documents performed by the State Medicines Control Agency.
\n
2.The State Medicines Control Agency shall protect the rights of consumers.
\n
3.Control shall be exercised in compliance with this Law and other legal acts and also having regard to the Compilation of Community Procedures on Inspections and Exchange of Information adopted on behalf of the European Commission by the European Medicines Agency.
\n
4.State control of veterinary pharmacy shall be exercised by the State Food and Veterinary Agency and the institution authorised by it – the Lithuanian State Inspectorate on Veterinary Preparations.
\n
Article 62Main Principles of Control of State Activities with Pharmaceutical Products
\n
1.The State Medicines Control Agency performing repeated inspections and samples control tests without prior notice must ensure compliance of activities involving pharmaceutical products with the requirements established by this Law and other legal acts.
\n
2.The State Medicines Control Agency may, without a prior notice, on its own initiative or at the request of another EEA state, the European Commission or the European Medicines Agency, perform an inspection of active substances used as starting materials within the premises of manufacturers or the medicinal product marketing authorisation holder if it is reasonable to assume that GMP is not complied with. Manufacturers of starting materials may be inspected at their own request.
\n
3.The State Medicines Control Agency shall inspect and evaluate:
\n
1)the manufacturing or commercial establishments of the manufacturers, importers of medicinal products, investigational medicinal products or active substances used as starting materials, as well as laboratories entrusted by the manufacturing licence holder with the task of carrying out checks;
\n
2)whether the manufacturing processes used in the manufacture of immunological products are properly validated and whether the batch-to-batch consistency is attained. As necessary, require the manufacturer and/or importer to submit copies of the control reports signed by the qualified person.
\n
3)whether the manufacturing and purifying processes used in the preparation of medicinal products derived from human blood or human plasma are properly validated, batch-to-batch consistency is ensured and the absence of specific viral contamination is guaranteed;
\n
4)performance of clinical tests or trials;
\n
5)the establishments, reports and documents relating to the carrying out of pharmacovigilance of the medicinal product marketing authorisation holder or another person entrusted by him to implement pharmacovigilance;
\n
6)third country manufacturers where there are grounds for that and the agreements of the European Community with third countries are not violated;
\n
7)legal persons upon submitting the application for the issuance of a licence for pharmaceutical activity:
\n
8)carrying out the advertising of medicinal products, medicinal purpose products according to the requirements laid down in this Law and the Law on Advertising;
\n
9)other activities involving medicinal products and the entities related to the activities within the competence established by the Regulations of State Medicines Control Agency.
\n
Article 63Rights of State Medicines Control Agency Employees Performing Actions of control
\n
1.The State Medicines Control Agency employees performing actions of control shall have the right to:
\n
1)to receive all information and documents related to the object inspection required in order to assess compliance with the established requirements;
\n
2)upon presenting the certificate of employment and the order, freely and without a prior notice during the working hours of the licence holder and at other hours – having enlisted, according to the procedure established by law, the assistance of competent law enforcement authority officers, enter all establishments in the places of activities specified in the licence, inspect, according to their competence, the establishments, equipment, installations, resources, the actions performed, the staff composition, their qualification etc., seeking to establish compliance with the requirements set by this Law and other regulations;
\n
3)issue mandatory instructions according to their competence;
\n
4)use technical means necessary for implementing effective control;
\n
5)enlist the assistance of necessary experts to participate in the inspection of the activities and the assessment of their compliance with the established requirements;
\n
6)to carry out control verifications and control purchases of medicinal products;
\n
7)exercise other rights according to the procedure established by this Law and other legal acts and apply other methods of inspection;
\n
8)take free samples for investigation.
\n
2.In the cases when it is necessary to enter the legal person’s establishment not in the working hours or when the inspected legal person fails to comply with the lawful instructions of the State Medicines Control Agency employees performing control activities or when it is necessary to perform in the course of the inspection certain actions which the employees of the State Medicines Control Agency have no right to perform under the effective laws the State Medicines Control Agency must apply to the competent law enforcement authority according to the procedure established by laws with a request to assist it to implement its rights or to duly perform its functions.
\n
3.The employees who perform the actions of control must, when inspecting, verify the effect and risk to public health of the established shortcomings and infringements and, as necessary, take all the appropriate actions or perform other necessary actions according to the procedure established by the Minister of Health. The State Medicines Control Agency employees, having established when performing control actions, the presence of a criminal act or any other violations of law, the investigation of which falls outside the sphere of their competence, shall inform law enforcement or the relevant controlling authority or institution thereof.
\n
4.The actions of employees specified in this Law may be appealed against according to the procedure established by legal acts.
\n
Article 64Documents of Control
\n
1.The results of every inspection shall be recorded in the certificate of inspection, in which, in addition to other information, conclusions regarding the compliance of the activities with the established requirements shall be presented. The inspected persons shall have the right to present in the course of inspection their explanations in respect of the object of inspection and other circumstances related to inspection. Written explanations and proofs shall be presented to the State Medicines Control Agency employees performing control actions and a notice to the effect shall be made in the certificate of inspection.
\n
2.It shall be indicated when filling up a certificate for the legal person seeking to be issued a licence to engage in pharmaceutical activity or for the licence holder whether the activities performed by him are in compliance with the good manufacturing practice or good distribution practice or the good pharmacy practice regulations. Inspecting the conduct of clinical trial their compliance with good clinical practice shall be assessed. The contents of the certificate shall be made known to the legal person or, as necessary, the medicinal product marketing authorisation holder who has been inspected.
\n
3.If, after the completion of the investigation, it is established that the medicinal product manufacturing or wholesale distribution licence holder complies with the requirements of good manufacturing practice or distribution practice, he must be within 90 days after the investigation issued a good manufacturing practice or good distribution practice certificate according to the procedure established by the Minister or Health.
\n
Article 65Validity of Inspections Carried out by other EEA States
\n
1.The conclusions of investigations by other authorised institutions of the EEA states adopted with respect to manufacturing, import, clinical investigation, wholesale distribution, pharmacovigilance shall be valid in the Republic of Lithuania.
\n
2.In exceptional cases, if for reasons connected with public health the State Medicines Control Agency cannot agree to the conclusions indicated in paragraph 1 of this Article, it shall notify the European Commission and the European Medicines Agency thereof.
\n
CHAPTER XV
\n
SANCTIONS FOR MARKETING OF A MEDICINAL PRODUCT OR MEDICINAL PURPOSE PRODUCTS
\n
Article 66Suspension, Revocation, Change in the Terms of Marketing and Marketing Authorisation of a Medicinal Product
\n
1.The State Medicines Control Agency shall suspend or revoke the marketing or marketing authorisation certificate of a medicinal product or approve the varying of its terms upon establishing at least one of the following grounds:
\n
1)the medicinal product is harmful under normal conditions of use;
\n
2)the medicinal product lacks in efficacy ;
\n
3)under normal conditions of use the benefit/risk balance of the medicinal product is unfavourable;
\n
4)the quantitative and/or qualitative composition of the medicinal product does not correspond to the declared composition;
\n
5)the information and documents submitted together with the application for the medicinal product marketing authorisation are erroneous or not supplemented according to the procedure established in paragraph 1 of Article 15;
\n
6)control of the medicinal product and/or its constituents or control at intermediate stages of the manufacturing process specified in the documents submitted together with the application for the marketing authorisation is not carried out.
\n
2.Having suspended the marketing or marketing authorisation certificate of the medicinal product the State Medicines Control Agency shall set a period not exceeding 12 months during which the medicinal product marketing or marketing authorisation certificate holder shall submit to the State Medicines Control Agency supplementary evidence required for eliminating the grounds established in paragraph 1 of this Article . If the medicinal product marketing or marketing authorisation certificate holder presents the evidence within the established time period, the State Medicines Control Agency shall adopt a decision to lift the suspension of marketing or marketing authorisation certificate for the medicinal product. Otherwise the marketing or marketing authorisation certificate for the medicinal product shall be revoked.
\n
3.The efficacy of a medicinal product shall be considered to be lacking when it is established that the therapeutic results for which it is used cannot be obtained with the medicinal product.
\n
4.The State Medicines Control Agency must suspend or revoke manufacturing authorisation of a group of medicinal products or all products the manufacturing whereof does not comply with the manufacturing conditions approved when granting marketing or marketing authorisation certificate.
\n
5.Having adopted a decision to suspend or revoke the marketing or marketing authorisation certificate, the State Medicines Control Agency shall accordingly update the Register of Medicinal Products of the Republic of Lithuania and forthwith publish a notice in the media of the suspension or revocation of the marketing or marketing authorisation certificate.
\n
6.Upon suspending the marketing or marketing authorisation certificate of a medicinal product its marketing or supply of the medicinal product to the market shall be prohibited.
\n
7.Upon the revocation under this Article of the medicinal product marketing or marketing authorisation certificate the product must be withdrawn from the market.
\n
8.The medicinal product marketing authorisation holder shall ensure the implementation of provisions of paragraphs 6 and 7 of this Law.
\n
Article 67Prohibition of Supply to the Market of a Medicinal Product and Withdrawal from the Market
\n
1.The State Medicines Control Agency shall, without prejudice to Article 66 of this Law, prohibit to supply a medicinal product to the market and withdraw it from the market upon establishing at least one of the following circumstances:
\n
1)the medicinal product is harmful under normal conditions of use;
\n
2)the medicinal product is lacking in efficacy;
\n
3)under normal conditions of use the benefit/risk balance of the medicinal product is unfavourable;
\n
4)the quantitative and/or qualitative composition of the medicinal product is not consistent with the declared composition;
\n
5)control of the medicinal product and/or its constituents or control at the intermediate stages of the manufacturing process, specified in the documents presented together with the application for the marketing authorisation is not carried out or requirements and obligations connected with the granting of marketing authorisation are not complied with.
\n
2.The State Medicines Control Agency shall have the right to prohibit by a justified decision to supply to the market only those batches of the medicinal product which give rise to doubts according to the circumstances specified in paragraph 1 of this Article or to apply their full or partial removal.
\n
3.The State Medicines Control Agency may suspend the manufacture or imports of medicinal products coming from third countries where the Articles of this Law are not complied with.
\n
Article 68Suspension and Revocation of Marketing Authorisation Certificate of Medicinal Purpose Products
\n
1.The State Medicines Control Agency shall suspend or revoke the marketing authorisation certificate of the medicinal purpose products if at least one of the following grounds is established:
\n
1)the medicinal purpose product does not meet the recognised modern quality or safety requirements;
\n
2)it transpires that the documents accompanying the application for marketing authorisation of the medicinal purpose product are unlawful, erroneous or misleading;
\n
3)the medicinal purpose product is harmful;
\n
4)the qualitative and/or quantitative composition of the medicinal purpose product is not consistent with the declared composition;
\n
5)the marketing authorisation certificate holder of the medicinal purpose product violates the terms of the marketing authorisation certificate;
\n
6)this is required by the marketing authorisation certificate holder of the medicinal purpose product.
\n
2.Having suspended the marketing authorisation certificate of the medicinal purpose product the State Medicines Control Agency shall set a period not exceeding 12 months during which the holder of the marketing authorisation certificate of the medicinal purpose product shall submit to the State Medicines Control Agency supplementary evidence required for eliminating the grounds established in paragraph 1 of this Article. If the holder of the marketing authorisation certificate of the medicinal purpose product submits the evidence within the established time period, the State Medicines Control Agency shall adopt a decision to lift the suspension of the marketing authorisation certificate of the medicinal purpose product. Otherwise the marketing authorisation certificate of the medicinal purpose product shall be revoked.
\n
3.The State Medicines Control Agency having adopted the decision to suspend or revoke the marketing authorisation certificate shall forthwith publish a notice in the media of the suspension or revocation of the marketing authorisation certificate.
\n
4.After variations under this Article have been made to the terms of the marketing authorisation certificate of the medicinal purpose product, its marketing shall be conducted in compliance with the variations to the terms of the certificate.
\n
5.Upon suspending under this Article marketing authorisation certificate of a medicinal product, its marketing and supply to the market shall be prohibited.
\n
6.Upon the revocation under this Article of the marketing authorisation of a medicinal purpose product, the product must be withdrawn from the market.
\n
CHAPTER XVI
\n
INTERNATIONAL CO-OPERATION
\n
Article 69Cooperation with the EU Institutions and the Competent Authorities of other EEA States
\n
1.The State Medicines Control Agency must cooperate and exchange information with the institutions of the European Union, competent authorities of other EEA states and the World Health Organisation For that purpose the Agency must:
\n
1)submit copies of manufacturing licences and GMP certificates (except for GMP certificate for traditional herbal medicinal products) to the European Medicines Agency; it shall enter the data in the Community Data Base. If it is established during the inspection that the manufacturer, importer does not comply with the GMP requirements, the corresponding information shall be forthwith submitted to the European Medicines Agency and published in the Community data base;
\n
2)at the request of the European Commission or any EEA state, present all the required information concerning the wholesale distribution licences issued according to this Law and other legal acts;
\n
3)forthwith inform the European Commission and other EEA states of the suspension of the medicinal products wholesale distribution licence, lifting the suspension and revocation of the licence.;
\n
4)if the holder of the medicinal products wholesale distribution licence of another EEA state does not comply with the terms of licensed activity, engages in activities not corresponding to the licence information and data, notify thereof the European Commission and the EEA state which issued the wholesale distribution licence to the licence holder;
\n
5)exchange information with the competent authorities of other EEA states and participate in the common information systems necessary to ensure compliance with the terms of manufacturing, wholesale distribution licences, good manufacturing practice certificates and authorisation documentation;
\n
6)upon reasoned request forthwith submit to the authorised authorities of another EEA state a document of inspection of compliance of the manufacturer, importer with the good manufacturing practice requirements and/or pharmacovigilance requirements; as necessary the State Medicines Control Agency must request the authorities to present to it such information;
\n
7)forthwith notify the European Medicines Agency of the decisions to issue a medicinal product marketing or marketing authorisation certificate, to refuse to issue it or to revoke it, to change the decision to refuse to issue the medicinal product marketing or marketing authorisation certificate or to revoke it, to prohibit to supply medicinal products to the public or to withdraw them from the market, stating the reasons for such actions;
\n
8)make known to other Member States all information necessary to ensure the quality and safety of homeopathic products manufactured and supplied to the Community;
\n
9)forward to the European Medicines Agency the information it received from the medicinal products manufacturing authorisation holder regarding the suspension of supply to the public of the medicinal product or its withdrawal from the market;
\n
10)forthwith bring to the attention of the World Health Organisation the information relating to the actions specified in subparagraphs 7 and 9 of this Article, if they may affect the protection of public health in third countries and forward a copy of the information to the European Medicines Agency.
\n
2.The State Medicines Control Agency, at the request of the manufacturer, the exporter or the competent authority of an importing third country, shall issue a document certifying that a manufacturer of medicinal products is in possession of the manufacturing authorisation When the manufacturer is not in possession of a marketing authorisation, he shall provide the State Medicines Control Agency with a declaration explaining no marketing authorisation is available.
\n
3.The certificate specified in paragraph 2 of this Article shall be issued taking into account the administrative agreements adopted by the World Health Organisation If the medicinal product intended for export has been granted marketing authorisation in the Republic of Lithuania, the summary of the product characteristics shall also be submitted.
\n
CHAPTER XVII
\n
VETERINARY PHARMACEUTICAL ACTIVITY
\n
Article 70Granting Marketing Authorisation of Veterinary Pharmaceuticals
\n
1.Only veterinary pharmaceuticals registered in the Register of Veterinary Pharmaceuticals of Lithuania may be supplied to the market of the Republic of Lithuania.
\n
2.The Register of Veterinary Pharmaceuticals shall be set up by the Government of the Republic of Lithuania. The leading management body of the Register shall be the State Food and Veterinary Service, the management body shall be the Lithuanian State Inspection of Veterinary Preparations.
\n
3.Veterinary pharmaceuticals shall be granted marketing authorisation according to the procedure established by the State Food and Veterinary Service in compliance with the national, mutual recognition or decentralised procedures.
\n
4.In order to be granted marketing authorisation of a veterinary pharmaceutical, the applicant must present the following documents:
\n
1)an application in the form established by the State Food and Veterinary Service;
\n
2)administrative information and scientific documents required to evidence the quality, safety and effectiveness of veterinary pharmaceutical.
\n
5.A state fee of the established amount shall be paid for granting marketing authorisation of a veterinary pharmaceutical.
\n
6.The decision on the granting of marketing authorisation of the veterinary pharmaceutical in the Register of Veterinary Pharmaceuticals shall be adopted not later then within 210 days from the receipt of the application. The time within which the applicant provides additional documents, information and, as necessary, verbal and/or written explanations shall not be included in the time of examination of the application.
\n
7.A veterinary pharmaceutical shall not be registered in the Register of Veterinary pharmaceutical, its marketing authorisation shall be suspended or revoked, it:
\n
1)under normal conditions of use the benefit/risk balance of the veterinary pharmaceutical is unfavourable;
\n
2)the efficacy of the veterinary pharmaceutical is not sufficiently substantiated by the applicant or the veterinary pharmaceutical has no therapeutic effect on the animal species to which it is intended.
\n
3)quantitative and qualitative composition of the veterinary pharmaceutical is not in compliance with the declared composition;
\n
4)the withdrawal period recommended by the applicant is not sufficiently long to ensure that the foodstuffs obtained from the treated animal have no residues that may endanger the consumer’s health or is not sufficiently justified;
\n
5)labelling or package leaflet does not meet the established requirements;
\n
6)the veterinary pharmaceutical is offered for sale for a use prohibited under other provision of EEA states;
\n
7)it turns out that erroneous data has been submitted about the veterinary pharmaceutical.
\n
8.The marketing authorisation holder shall be responsible for the quality, safety and efficacy of the registered veterinary pharmaceutical.
\n
9.The State Food and Veterinary Service shall establish:
\n
1)the procedure of temporary import and use of veterinary pharmaceuticals not registered in the Republic of Lithuania;
\n
2)the procedure of temporary import and use of veterinary pharmaceuticals intended for scientific and clinical trial purposes that are not authorised for use in the Republic of Lithuania
\n
Article 71Manufacture, Import and Supply to the Market of Veterinary pharmaceuticals
\n
1.Legal persons and branches in EU member states or EEA states of enterprises established in the Republic of Lithuania (hereinafter referred to as legal persons) who wish to manufacture or import veterinary pharmaceuticals, must:
\n
1)have at its disposal premises, technical equipment and control facilities complying with the requirements set by the State Food and Veterinary Service;
\n
2)employ at least one qualified person responsible for manufacture and/or import whose qualification would meet the requirements set by the State Food and Veterinary Service;
\n
3)meet other requirements set by this Law and other legal acts.
\n
2.Legal persons who wish to supply to the market veterinary pharmaceuticals must: have at their disposal premises, technical equipment that would meet the requirements established by the State Food and Veterinary Service;
\n
2)employ at least one person – manager of veterinary pharmaceutical activity , responsible for the performed veterinary pharmaceutical activity whose qualification would meet the requirements set by the State Food and Veterinary Service;
\n
3)meet other requirements set by this Law and other legal acts.
\n
3.The State Food and Veterinary Service shall set the procedure for prohibiting the supply to the market and withdrawal from the market of veterinary pharmaceuticals.
\n
Article 72Veterinary Pharmacovigilance
\n
1.The State Food and Veterinary Service shall implement veterinary pharmacovigilance.
\n
2.Persons authorising and manufacturing veterinary pharmaceuticals, veterinary pharmaceutical enterprises, veterinary surgeons, health professionals must notify, according to the procedure established by the State Food and Veterinary Service, of the animal’s adverse reaction to the veterinary pharmaceutical administered, detrimental effect of veterinary pharmaceuticals to human, animal health and environment.
\n
Article 73Licensing of Veterinary Pharmaceutical Activity
\n
1.In the Republic of Lithuania legal and natural persons may engage in veterinary pharmaceutical activity only being in possession of a licence issued by the State Food and Veterinary Service (hereinafter referred to as the licence of veterinary pharmaceutical activity) 2. A veterinary pharmaceutical activity licence shall authorise a person to engage in activities connected only with veterinary pharmaceuticals and the types of licensed activities specified in the licence.
\n
3.Rules for the licensing of veterinary pharmaceutical activity of legal persons, rules for the licensing of veterinary pharmaceutical activity of natural persons shall be approved by the Government.
\n
4.Legal persons and branches established in the Republic of Lithuania of enterprises established in EU member states and other EEA states (hereinafter referred to as legal persons) shall be issued licences of veterinary pharmaceutical activity of the following types:
\n
1)licence for the manufacture of veterinary pharmaceuticals;
\n
2)licence for wholesale distribution of veterinary pharmaceuticals;
\n
3)veterinary pharmaceutical activity licence;
\n
4)licence for the import of veterinary pharmaceuticals;
\n
5.Legal persons carrying out partial manufacture, dividing up or repacking shall also be required to posses a licence for the manufacture of veterinary pharmaceuticals.
\n
6.In order to be issued a veterinary pharmaceutical activity licence a natural or a legal person must submit an application and other documents prescribed by the Rules of Licensing of Legal Persons Veterinary Pharmaceutical activity and of Licensing of Natural Persons Veterinary Pharmaceutical activity. The applicant shall be responsible for the correctness of the data and information submitted in the application.
\n
7.The State Food and Veterinary Service shall adopt a decision to issue a veterinary pharmaceutical activity licence only having ascertained that the submitted data and information comply with the requirements set in this Law and other legal acts.
\n
8.A licence shall be issued only to those natural persons who have acquired professional qualification of a veterinary surgeon or veterinary pharmacist. The activities of a veterinary paramedic and pharmacist’s assistant (pharmacy technician) in veterinary pharmaceutical enterprises shall not be subject to licences. Veterinary paramedics and pharmacist’s assistants (pharmacy technicians) shall work in veterinary pharmaceutical enterprises under the control exercised, according to the procedure established by the State Food and Veterinary Service, by the veterinary surgeon or a pharmacist in possession of a licence for veterinary pharmaceutical activity.
\n
9.A veterinary pharmaceutical activity licence shall be issued only to those legal entities which employ a natural person(s) in possession of a veterinary pharmaceutical activity licence and one of them has been appointed manager of the veterinary pharmaceutical activity of the enterprise, while the enterprise for the manufacture or import of veterinary pharmaceuticals employs a qualified person in possession of a natural person’s licence for veterinary pharmaceutical activity.
\n
10.Licences for veterinary pharmaceutical activity shall be issued to legal and natural persons for an indefinite time period.
\n
11.A state fee of the established amount shall be paid for the issuing of the veterinary pharmaceutical activity licence.
\n
12.A veterinary pharmaceutical activity licence shall not be issued to legal and natural persons (shall not be updated or supplemented ) if:
\n
1)not all the required documents specified in the Rules for the Licensing of Veterinary Pharmaceutical activity of Legal Persons and Rules for the Licensing of Veterinary Pharmaceutical activity of Natural Persons have been submitted and the applicant has not complied with the demand of the State Food and Veterinary Service to submit the lacking documents;
\n
2)not fully or incorrectly filled in documents have been submitted and the applicant has not complied with the demand of the State Food and Veterinary Service to eliminate the shortcomings;
\n
3)incorrect data, lacking and inaccurate information has been submitted, and the applicant has not complied with the demand of the State Food and Veterinary Service to make good the shortcomings;
\n
4)the veterinary pharmaceutical activity licence of the legal or natural person has been revoked and less than one year has lapsed from the revocation of the veterinary pharmaceutical activity licence; the provision shall not apply if the legal person terminates its activities of its own free will or the natural person submits an application to revoke the licence;
\n
5)a State fees of the established amount have not been paid;
\n
6)the natural person has not acquired the qualifications of a veterinary surgeon or a pharmacist
\n
7)the person is prohibited from engaging in the veterinary pharmaceutical activity by the effective court decision;
\n
8)legal capacity of the legal person has been restricted by an effective court decision;
\n
13.Duties of the legal person holding a veterinary pharmaceutical activity licence:
\n
1)to comply with the provisions and the requirements of this Law, the Law on Veterinary pharmaceutical, the Rules for the Licensing of Veterinary Pharmaceutical activity of Legal Persons and other legal acts regulating veterinary pharmaceutical activity;
\n
2)to provide conditions for the improvement of employees’ qualifications;
\n
3)to provide conditions for the manager of veterinary pharmaceutical activity or the qualified person to carry out veterinary pharmaceutical activity in compliance with the requirements of this Law;
\n
4)to notify the State Food and Veterinary Service of the replacement of the manager of veterinary pharmaceutical activity or the qualified person, suspension of the licensed activity, refusal of one’s own volition to engage in the licensed activity or of the changes in the licensed activity;
\n
5)allow the controlling state institution to inspect the licensed activity carried out.
\n
14.Duties of the natural person holding a veterinary pharmaceutical activity licence:
\n
1)to comply with the provisions and the requirements of this Law, the Law on Veterinary pharmaceutical, the Rules for the Licensing of Veterinary Pharmaceutical activity of Natural Persons and other legal acts regulating veterinary pharmaceutical activity;
\n
2)to improve one’s qualification according to the procedure established by the State Food and Veterinary Service;
\n
3)to notify the State Food and Veterinary Service of the suspension of the licensed activity or the refusal of one’s own volition to engage in licensed activity.
\n
15.Rights of legal and natural persons holding the veterinary pharmaceutical activities licence:
\n
1)to engage in licensed activity;
\n
2)to receive explanation in the case of veterinary pharmaceutical licence suspension, licence revocation;
\n
3)take part in considering the suspension of the veterinary pharmaceutical activity licence or revocation of the veterinary pharmaceutical activity licence issued in their name;
\n
4)to appeal to the court against the decisions of the State Food and Veterinary Service concerning the suspension, revocation of the veterinary pharmaceutical activity licence according to the procedure established by the legal acts of the Republic of Lithuania.
\n
16.The holder of the veterinary pharmaceutical activity licence shall have no right to authorise another person to carry out on his behalf the activity specified in the veterinary pharmaceutical activity licence or to give over under contract to another person the right to carry out the activity.
\n
17.The State Food and Veterinary Service shall suspend the veterinary pharmaceutical activity licence:
\n
1)if the legal or natural person does not comply with the terms of licensed activity and duties of the veterinary pharmaceutical activity licence holder;
\n
2)to a legal person if criminal or administrative proceedings have been instituted following the infringements of veterinary pharmaceutical activity committed by the qualified person or the manager of veterinary pharmaceutical activity for the period pending the hearing or investigation of the case, except where another person is appointed to act for the qualified person or manager of veterinary pharmaceutical activity;
\n
3)to a legal person if the qualified person or the manager of veterinary pharmaceutical activity of the legal person is prohibited by an effective court decision to engage in the licensed activity pending the appointment to the duties of another person meeting the requirements of this Law and other legal acts;
\n
4)if the natural persons holding a veterinary pharmaceutical activity licence after a written warning fail to improve their qualification according to the qualification improvement procedure established by the State Food and Veterinary Service;
\n
5)at the request of the legal or natural person holding a veterinary pharmaceutical activity licence.
\n
18.After the causes for suspension of the veterinary pharmaceutical activity licence have been eliminated, the suspension of the veterinary pharmaceutical activity licence shall be lifted.
\n
19.The State Food and Veterinary Service shall revoke the licence for veterinary pharmaceutical activity if:
\n
1)the holder of the veterinary pharmaceutical activity licence terminates the licensed activity and submits to the State Food and Veterinary Service an application to revoke the veterinary pharmaceutical activity licence;
\n
2)upon suspension of the veterinary pharmaceutical activity licence the holder of the veterinary pharmaceutical activity licence fails to eliminate within the established time period the violations of the licensed activity;
\n
3)the authorised body establishes that upon the suspension of the veterinary pharmaceutical activity licence the legal person or its establishment further engages in veterinary pharmaceutical activity;
\n
4)the legal person is in liquidation, a bankruptcy proceedings have been instituted against it or out-of court bankruptcy procedure is applied with respect to the legal person or the legal person is being reorganised, ceases to exist as an independent economic entity;
\n
5)it transpires that erroneous data has been submitted seeking the issuance of the veterinary pharmaceutical activity licence;
\n
6)the veterinary pharmaceutical activity licence holder, upon the suspension of its veterinary pharmaceutical activity licence and upon the lifting of the suspension of the veterinary pharmaceutical activity licence, for the second time within 12 months committed a violation related to the licensed activity;
\n
7)the veterinary pharmaceutical activity licence holder infringes the requirements of legal acts regulating veterinary pharmaceutical activity within the time period set for the elimination of shortcomings, when the veterinary pharmaceutical activity licence is suspended, or infringes the requirements of legal acts regulating veterinary pharmaceutical activity, when irreparable damage is caused by the activity to human, animal and the environment.
\n
8)the legal or natural person has been prohibited from engaging in licensed activity by an effective court decision;
\n
9)the veterinary pharmaceutical activity licence holder – a natural person - does not improve his qualification after the warning or suspension of the veterinary pharmaceutical activity licence because of the qualification improvement according to the procedure established by the State Food and veterinary Service.
\n
CHAPTER XVIII
\n
ENSURING THE IMPARTIALITY OF PERSONS AND LIABILITY FOR LEGAL VIOLATIONS
\n
Article 74Ensuring the Impartiality of Decision Making Persons
\n
1.Persons taking part in the making of decisions connected with the granting of marketing authorisation for medicinal products, issuance of permit for parallel import, granting of clinical trials authorisation, issuance of medicinal purpose registration certificate, issuance of licences for pharmaceutical activity, who are exercising control over the activity with pharmaceutical products should not have any financial or other interests related to the matter under consideration, pharmaceutical industry or other persons who can affect their impartiality. Persons having such interests must declare them according to the procedure established by legal acts.
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2.The State Medicines Control Agency shall grant the public access to its rules of procedure or those of the commissions formed at the State Medicines Control Agency, the agendas of the meetings, the adopted decisions and motives for their adoption. The adopted decisions and their motives shall be published in the webpage of the State Medicines Control Agency.
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Article 75Liability for Violations
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For violations of activity involving pharmaceutical products and for veterinary pharmaceutical activity violations as well as for illegal activity natural and legal persons shall be held liable according to the procedure established by legal acts of the Republic of Lithuania
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CHAPTER IXX
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FINAL PROVISIONS
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Article 76Entry into Force of the Law
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1.The provisions of paragraph 4 of Article 12, paragraph 8 of Article 14, paragraph 9 of Article 17, paragraph 5 of Article 18, paragraph 8 of Article 20, paragraph 6 of Article 60 and paragraph 1 of Article 61 on the introduction of State fees shall enter into force on 1 July 2006. Until the entry into force of this part a remuneration in the amount approved by the Minister of Health shall be payable for the services provided by state establishments and for the issuance of documents specified in paragraph 4 of Article 12, in paragraph 8 of Article 14, in paragraph 9 of Article 17, in paragraph 5 of Article 18, in paragraph 8 of Article 20, in paragraph 6 of Article 60, and in paragraph 1 of Article 61.
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2.Paragraph 1 of Article 42 of this Law shall come into force on 1 January 2007.
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3.The provisions of paragraph 2 of Article 5 of this Law shall not be applicable to pharmacy technicians holding a licence for pharmaceutical activity. The State Medicines Control Agency shall enter them into the List of Pharmacist’s Assistants (Pharmacy technicians) based on the information on the issued and valid licences of pharmaceutical activity.
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4.The provisions of paragraph 5 of Article 5 of the Law shall enter into force a year after the date of entry into force of the Law.
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5.The pharmacy technicians who have been issued a licence for pharmaceutical activity prior to the entry into force of this Law or persons who started their pharmacy technician studies prior to the entry into force of this Law, who will acquire the professional qualification of the pharmacist’s assistant (pharmacy technician) after the entry into force of this Law may provide the pharmacy service according to the procedure established by the Minister of Health but for not longer than until 31 December 2015. From 1 January 2016 the persons specified in this part shall have the right to sell/dispense medicinal products under the control of the pharmacist. The pharmacist shall be liable for the activity.
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6.Legal persons who are in possession of the pharmaceutical activity licence (except if they have a licence of the production community pharmacy to sell/dispense the Magistral Formula medicinal products), who until the entry into force of this Law supplied medicinal products to legal persons having a licence for the provision of personal health care services may supply medicinal products not longer than until 31 December 2006.
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7.Pharmacy branches established prior to the entry into force of this Law which do not meet the set requirements may engage in the activities for no longer than until 31 December 2015.
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8.The relations which emerged prior to the entry into force of this Law shall be continues and the provisions of this Law shall be applied with respect to them. The laws and other legal acts which used to regulate the relations attributed within the sphere of regulation of this Law shall be valid to the extent not contrary to this Law except in cases when this Law gives precedence to the provisions of other laws or legal acts.
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9.The provisions of other laws of the Republic of Lithuania shall be applied to legal relations regulated by this Law to the extent they are not regulated by this Law.
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Article 77Proposals to the Government and other State Institutions Indicated in the Law
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The Government of the Republic of Lithuania and other State institutions indicated in this Law shall review the legal acts related to the implementation of the provisions of this Law and, as necessary, draw up appropriate drafts for the amendment thereof or adopt new legal acts.
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Article 78Invalidation of Legal Acts
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Upon the entry into force of this Law, the following laws shall be repealed:
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1)Law Republic of Lithuania on Pharmaceutical Activities;
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2)Law “on the Amending and Supplementing the Law of the Republic of Lithuania on Pharmaceutical Activities;
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3)Law of the Republic of Lithuania on Amending Articles 1, 5, 7, 10, 12, 14, 16, 17, 19, 21, 22, 23, 24 of the Law on Pharmaceutical Activities and Supplementing the Law with Article 25;
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4)Law on Amending Articles 10, 14 of Law Republic of Lithuania on Pharmaceutical Activities;
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5)Law on Amending Articles 17, 21, 22, 23 24 of the Law of the Republic of Lithuania on Pharmaceutical Activities;
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6)Law on Amending Articles 1, 4, 5, 10, 11, 15, 17, 19, 20 of Law Republic of Lithuania on Pharmaceutical Activities and adding Articles 10¹, 17¹;
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7)Law on amending the introduction, articles 1, 2, 4, 5, 6, 7, 8, 10¹, 13, 14, 16, 19, 20, 21, 22, 24, 25of the Law Republic of Lithuania on Pharmaceutical Activities and adding articles 10², 19¹, 20¹, 20², 20³ and Annex to the Law;
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8)Law of the Republic of Lithuania on Medicines;
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9)Law on Amending Article 11 of the Law of the Republic of Lithuania on Medicines;
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10)Law on Amending Articles 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14 of the Law of the Republic of Lithuania on Medicines;
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11)Law on Amending Articles 2, 3, 11 of the Law of the Republic of Lithuania on Medicines and supplementing the Law with Annex.
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I promulgate this Law passed by the Seimas of the Republic of Lithuania \\ PRESIDENT OF THE REPUBLIC VALDAS ADAMKUS Annex to Law of the Republic of Lithuania of 22 June 2006 No X-709 IMPLEMENTED LEGAL ACTS OF THE EUROPEAN UNION 1. Council Directive of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (89/105/EEC) (OJ 2004 special edition, Chapter 5, Volume 1, p. 345).
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2.Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. (OJ 2004 special edition, Chapter 13, Volume 26, p. 299).
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3.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 (OJ 2004 special edition, Chapter 13, Volume 27, p. 69)(as last amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (OJ 2004 special edition , Chapter 13 Volume 34, p. 262) and by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (OJ 2004 special edition, Chapter 13 Volume 34 p. 262) and Directive 2004/24/EC of the European Parliament and of the Council ( OJ 2004 special edition, Chapter 13, Volume 34, p. 313).
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4.Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (text with EEA relevance). (OJ 2004 special edition, Chapter 13, Volume 32, p. 424).
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5.Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. (OJ 2004 special edition, Chapter 13, Volume 34, p. 313).
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6.Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (text with EEA relevance) (OJ 2004 special edition, Chapter 13, Volume 34, p. 262).
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7.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 of supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (text with EEA relevance) (OJ 2004 special edition, Chapter 13, Volume 34, p. 229).
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8.Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (text with EEA relevance) (OJ 2005 L 091, p. 13).