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REPUBLIC OF LITHUANIA

REPUBLIC OF LITHUANIA Republic Of lithuania LAW ON MEDICINES CHAPTER I GENERAL PROVISIONS Article

  1. Objectives of the Law This law shall establish the basic principles for the registration, manufacture and placing on the market of medicines, the procedure for quality control of medicines, characteristics of clinical trials of the test medicine, the procedure for the evaluation of risk factors of medicines, conditions of use of veterinary medicines. Article
  2. Definitions
  3. Diagnostic allergens - medicines containing antigens or half-antigens intended for detecting specific defensive substances in humans and animals.
  4. Diagnostic antibodies - medicines containing antigens or half-antigens intended for diagnosing diseases.
  5. Diagnostic serums - medicines manufactured as serums and intended for diagnosing diseases.
  6. Proprietary medicines - finished medicines having the name of the manufacturer and supplied to the consumer in the original packaging of the manufacturer.
  7. Homeopathic preparations - preparations manufactured in accordance with the methods of homeopathic production.
  8. Blood preparations - medicines derived from blood or its components.
  9. Chief researcher (in clinical trials of a medicine) - a medical degree holding doctor approved by the State Medicines Control Agency at the Ministry of Health for conducting the clinical trial of a concrete medicine.
  10. Radioactive medicines - medicines containing one or more radioactive isotopes with ionising radiation and used as medicines for these properties.
  11. Batch - a certain quantity of one kind of a medicine manufactured during one manufacturing cycle and having one quality certificate.
  12. Serums - medicines derived from human or animal blood, organs, their parts or secretions with specific antibodies. In this Law serums shall not be treated as blood products.
  13. Side effects of a medicine - undesirable effects during a prescribed use of a medicine.
  14. Test medicines - products containing chemical substances and designed to determine whether they can be prescribed for treatment, diagnosis and prophylaxis of diseases or for affecting physiological functions.
  15. Preparations of traditional medicine - products to which all the qualitative properties of a medicine cannot be ascribed but which are used traditionally as medicines.
  16. Medicines - products containing as their ingredients medicinal substances and designed for therapy of humans and animals, for diagnostic and prophylactic purposes and for affecting physiological functions. In the present Law the notion of medicine shall embrace only proprietary medicines and medicinal substances.
  17. Placing of a medicine on the market - storage of a medicine intended for sale or dispensing , and its offer for sale or dispensing.
  18. Manufacturer of the medicine - an enterprise accredited by the Government in a prescribed manner for manufacture of proprietary medicines in batches and for placing them on the market under its name.
  19. Clinical trial of a medicine - a trial of the effect of a test medicine on a human.
  20. Quality of a medicine - the sum of properties of a medicine characterised by its identity, purity, composition, other chemical, physical and biological properties and production technology.
  21. State Medicines Control Agency - an agency acting within the competence established by law at the Health Ministry.
  22. Vaccines - medicines containing antigens and assisting a human or an animal organism to produce defensive and protective substances.
  23. Veterinary premixes - multicomponent compounds containing vitamins, microelements, ferments, amino acids, antioxidants intended for prophylaxis and treatment of animal diseases.
  24. Veterinary medicines - medicines intended only for animals.
  25. Veterinary medicinal feed - feed with premixes of medicines intended for prophylaxis and treatment of animal diseases. CHAPTER II PRINCIPLES OF REGISTRATION OF MEDICINES Article
  26. State Registration of Medicines
  27. Only medicines registered in the Republic of Lithuania shall be used for the treatment of humans and animals, for diagnosis and prophylaxis of diseases or for affecting physiological functions. The procedure for use in exceptional cases of non-registered medicines shall be established by the Law on Pharmaceutical Activities.
  28. Registration of a medicine shall mean the recording of the product in the State Medicines Register subject to the expert examination of the documents and test samples the medicine submitted by the manufacturer, intended to determine the quality, safety and efficacy of the medicine.
  29. Medicines shall be recorded in the State Medicines Register.
  30. Registration of medicines (except veterinary medicines), radioactive medicines, homeopathic preparations, preparations of traditional medicine, medicinal bioproducts (toxins, serums, diagnostic allergens, diagnostic antigenes, diagnostic serums and vaccines), biotechnological products, blood preparations, medicated cosmetics and special purpose food products shall be effected and the Medicines Registration Regulations shall be approved by the State Medicines Control Agency.
  31. Registration of veterinary medicines shall be effected and the Veterinary Medicines Registration Regulations shall be approved by the State Veterinary Agency..
  32. The State Medicines Register shall be kept and its data shall be circulated by the State Medicines Control Agency and by the State Veterinary Agency. Article
  33. General Requirements for Registration of Medicines
  34. An application for registration of a medicine shall be submitted by the manufacturer of the medicine or by his authorised representative to the State Medicines Control Agency or the State Veterinary Agency.
  35. Together with the application for registration of a medicine, the applicant must submit for expert examination the following: 1) documentation of the type prescribed by the State Medicines Control Agency or the State Veterinary Agency; 2) samples of the medicine; 3) standard specimens of the medicinal substance; 4) other documentation and information necessary for expert examination of the medicine.
  36. The submitted information about the medicine must be objective and must conform to the standards of contemporary science.
  37. The manufacturer of the medicine must promptly notify the State Medicines Control Agency or the State Veterinary Agency if, before the completion of the registration procedure, he changes the data and documentation at his own initiative, also about a newly discovered side-effect of the medicine or other circumstances having a direct or indirect threat to the health of a human being or an animal.
  38. The manufacturer of the medicine shall cover the expenses incurred by the registration authority for the expert examination of the medicine and other registration services in a manner prescribed by the Ministry of Health or the State Veterinary Agency. Article
  39. Decision about the Registration of a Medicine
  40. The State Medicines Control Agency or the State Veterinary Agency shall adopt a decision about the registration of a medicine.
  41. After the expert examination the State Medicines Control Agency or the State Veterinary Agency shall decide whether the medicine submitted can be ascribed to the category of a medicine and assigns it to an appropriate group of medicines.
  42. The State Medicines Control Agency or the State Veterinary Agency shall have a right to refuse registration of a medicine if after the evaluation of the valid requirements for the medicine it is established that: 1) the documentation and information about the medicine is insufficient; 2) the quality of the medicine is inadequate; 3) the safety of the medicine is inadequate; 4) the efficacy of the medicine is inadequate.
  43. The State Medicines Control Agency or the State Veterinary Agency shall have the right to prescribe the manner of use of the medicine. Article
  44. Validity of the Medicine Registration Document
  45. After the registration of a medicinal product in the State Register of Medicines, the State Medicines Control Agency or the State Veterinary Agency shall issue to the manufacturer of the medicine a registration certificate. The form and requisites of the medicine registration certificate shall be set by the State Medicines Control Agency or the State Veterinary Agency.
  46. The medicine registration certificate shall be issued for a period not longer than five years. At the expiry of that term, the medicine can be used only subject to a renewed registration. The procedure for a renewed registration shall be established by the State Medicines Control Agency or the State Veterinary Agency. Article
  47. Temporary Removal of Medicines from the Market and Suspension of the Validity of Registration
  48. Medicines shall be removed from the market or validity of their registration shall be suspended in a manner prescribed by the registration regulations.
  49. After suspending validity of the registration of a medicine, the medicines shall be stricken off the State Register of Medicines. CHAPTER III MANUFACTURE AND MARKETING OF MEDICINES Article
  50. Marketing of Medicines
  51. Medicines manufactured in the Republic of Lithuania can be marketed subject to their registration in the Republic of Lithuania, conformity to the packaging text and labelling requirements set in the regulatory enactments approved by the State Medicines Control Agency or the State Veterinary Agency; the essential (reimbursed) medicines must have the purchase cost compensation rate and retail prices approved in a manner prescribed by the Ministry of Health.
  52. The manufacturer of the medicine can change the labelling and qualitative indicators of the medicine only in an established manner subject to an authorisation from the State Medicines Control Agency or the State Veterinary Agency.
  53. The manufacturer of a medicine shall be held responsible for the quality of the manufactured and marketed proprietary medicine.
  54. The State Medicines Control Agency or the State Veterinary Agency can request additional warnings and precautionary or identification marks about the medicine on the packaging, in the instruction for use of the medicine intended for health professionals or in the information for the user.
  55. Medicines imported into the Republic of Lithuania shall be given marketing authorisation provided: 1) medicines intended for medical purposes are registered in the Republic of Lithuania, conform to the requirements for the packaging text and labelling approved by the State Medicines Control Agency and have an accompanying instruction on the use of the medicine intended for health professionals and/or information for the user in Lithuanian; the essential (reimbursed) medicines must have the purchase cost compensation rate and retail prices approved in a manner prescribed by the Ministry of Health. The contents and manner of presentation of the instruction on the use of the medicine for health professionals and of the information for the user shall be established by the State Medicines Control Agency; 2) medicines intended solely for veterinary purposes are registered in the Republic of Lithuania, conform to the requirements for the packaging text and labelling approved by the State Veterinary Agency and have an accompanying instruction on the use of the medicine intended for veterinary health professionals and information about the veterinary medicine in Lithuanian. The contents and manner of presentation of the instruction for veterinary health professionals and of the information about the medicine shall be established by the State Veterinary Agency.
  56. Medicines intended for veterinary purposes must have the label “For veterinary use”.
  57. The name of the medicine and information about the product must not be misleading. CHAPTER IV QUALITY CONTROL OF MEDICINES Article
  58. Institutions Exercising Quality Control of Medicines Quality control of medicines shall be exercised by the State Medicines Control Agency and the State Veterinary Agency. Article
  59. Competence of the Institutions Exercising Quality Control of Medicines
  60. The State Medicines Control Agency or the State Veterinary Agency shall have the right to take a decision to ban placing on the market of medicines or remove them from the market, to prohibit the use of medicines for the production of other medicines provided: 1) the manufacturer of the medicine had no authorisation to manufacture it; 2) the obligatory quality control of the medicine is not being carried out; 3) the quality of medicines does not conform to the approved regulatory enactments on standardisation; 4) the term of use of the medicine has expired; 5) the packaging and labelling of the medicines is not in conformity with the established requirements.
  61. In exercising control of the quality of medicines the State Medicines Control Agency or the State Veterinary Agency shall have the right: 1) to inspect pharmaceutical enterprises, examine the documents relating to the quality control of medicines necessary for inspection, also to instruct and advise on pharmaceutical activities in a manner prescribed by the Ministry of Health; 2) to obtain free of charge for expert examination the necessary minimal sample quantity of medicines and other medicinal products on sale at pharmacies or which are available at wholesalers’ or manufacturers’ enterprises in a manner prescribed by the Ministry of Health. CHAPTER V CLINICAL TRIAL OF TEST MEDICINES Article
  62. Clinical Trial of Test Medicines
  63. Clinical trial of test medicines shall be regulated by laws, regulations of good practices of clinical trial of medicines approved by the Ministry of Health and other legal acts the observance whereof shall be controlled by the State Medicines Control Agency and other authorised institutions.
  64. Authorisation to undertake a clinical trial of a medicine shall be issued by the Medical Ethics Committee of Lithuania at the recommendation of the State Medicines Control Agency. The recommendation by the State Medicines Control Agency shall be prepared in accordance with the plan submitted by the chief clinical researcher and approved by the Ethics Committee of Biomedical Research.
  65. The manner of a clinical trial for veterinary medicines shall be established by the State Veterinary Agency. CHAPTER VI EVALUATION OF RISK FACTORS OF MEDICINES. INFORMATION ABOUT MEDICINES Article
  66. Evaluation of Risk Factors of Medicines
  67. Direct and indirect threat to the health of a human being, the public or an animal caused by the risk factors involved in the use of medicines shall be evaluated by the State Medicines Control Agency or the State Veterinary Agency.
  68. The manufacturer of a medicine must notify the State Medicines Control Agency or the State Veterinary Agency about the risk factors of the medicines he is manufacturing in a manner prescribed by the State Medicines Control Agency or the State Veterinary Agency.
  69. Reports by medical and veterinary professionals about side-effects, counter-indications or risk factors of medicines shall be registered by the State Medicines Control Agency or the State Veterinary Agency. Article
  70. Information about Medicines
  71. Information about medicines shall be regulated by the Law on Pharmaceutical Activities and other laws.
  72. The manufacturer of a medicine must provide information for medical professionals and users about the medicine he is manufacturing in a manner of providing information about medicines established by the State Medicines Control Agency or the State Veterinary Agency. CHAPTER VII VETERINARY MEDICINES Article
  73. Conditions of Use of Veterinary Medicines
  74. The use of veterinary medicines shall be established by the Law on Pharmaceutical Activities and the State Veterinary Agency.
  75. It shall be prohibited to use and register hormone preparations and growth stimulators hazardous for the health of human beings with the aim of increasing animal productivity and stimulating growth.
  76. The manner in which veterinary hormone preparations are used for the treatment of animals shall be established by the State Veterinary Agency.
  77. The State Veterinary Agency can prohibit the use of veterinary medicines, veterinary premixes, veterinary medicinal fodder for animals used for the production of foodstuffs if they can directly or indirectly have a harmful effect on the health of human beings. CHAPTER VIII FINAL PROVISIONS Article
  78. Liability Persons who violate the requirements of this Law shall be held liable under law. Article
  79. Entry into Force This Law shall enter into force on January 1,
  80. I promulgate this Law passed by the Seimas of the Republic of Lithuania. Algirdas Brazauskas President of the Republic Vilnius 19 November 1996 No.I-1633

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