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Official translation Official translation GOVERNMENT OF THE REPUBLIC OF LITHUANIA RESOLUTION No. 802 ON THE APPROVAL OF REGULATIONS ON LICENSING PHARMACEUTICAL ACTIVITIES 30 June 1998 Vilnius The Government of the Republic of Lithuania h a s r e s o l v e d:

  1. To approve the Regulations on Licensing Pharmaceutical Activities (attached hereto).
  2. To assign the Ministry of Health Care to issue and re-register licences for enterprises to engage in pharmaceutical activities as well as to suspend and revoke licences.
  3. Fixed-term licences for enterprises to engage in pharmaceutical activities issued prior to the entry of the present Resolution of the Government of the Republic of Lithuania into force shall be re-registered according to the Regulations on Licensing Pharmaceutical Activities approved by the present Regulation after their term of validity expires.
  4. To recognise as invalid: 4.
  5. Government Resolution No. 1241 “On the Approval of Regulations on Licensing Pharmaceutical Activities” of 25 October 1996 (Valstybės Žinios, No. 105–2412, 1996); 4.
  6. Government Resolution No. 1038 “On Partial Amendments to Resolution No. 1241 “On the Approval of Regulations on Licensing Pharmaceutical Activities” passed by the Government of the Republic of Lithuania on 25 October 1996” of 19 September 1997 (Valstybės Žinios, No. 88–2220, 1997). Prime Minister Gediminas Vagnorius Minister of Health Care Mindaugas Stankevičius APPROVED by Resolution No. 802 30 June 1998 Government of the Republic of Lithuania REGULATIONS ON LICENSING Pharmaceutical Activities General Part
  7. The present Regulations shall establish the procedure of issue, refusal to issue, suspension, withdrawal and re-registration of licences for enterprises to engage in pharmaceutical activities (except for activities related to narcotic and psychotropic medicines and medicinal substances).
  8. The following definitions are used for the purpose of the present Regulation: 2.
  9. “permit to manage pharmaceutical activities” shall mean a document issued by the Ministry of Health Care to a pharmaceutical chemist of the highest or the first qualification category granting the right to manage pharmaceutical activities; 2.
  10. “licence for an enterprise to engage in pharmaceutical activities” (hereinafter referred to as a “licence”) shall mean a document issued by the Ministry of Health Care certifying that the enterprise has the right and adequate conditions to engage in pharmaceutical activities.
  11. The Ministry of Health Care shall issue, re-register or refuse to issue licences, suspend them and revoke such suspension, as well as revoke licences. If an enterprise conducts pharmaceutical activities in several of its branches, it shall be issued a single licence indicating the addresses of such branches. Documents Required to Obtain or Re-Register a Licence
  12. An enterprise applying for a licence shall submit the following documents to the Ministry of Health Care: 4.
  13. an application (in the form established by the Ministry of Health Care) indicating the name of the enterprise, its address, telephone and code, address of premises where pharmaceutical activities will be conducted, character of the pharmaceutical activities for which a licence is requested, and date of submitting the application; 4.
  14. copies of its registration certificate and bylaws (except for enterprises that operate without bylaws); 4.
  15. copies of documents concerning the ownership of premises (lease agreement, documents of title, etc.) where the enterprise (or its branch) will conduct the said activities; 4.
  16. certificates issued by territorial state tax inspectorates and state social insurance companies confirming that the income of the enterprise has been declared and that taxes have been paid. Such certificates shall be issued not earlier than 30 days before submitting the application to obtain/re-register a licence; 4.
  17. a permit (hygiene certificate) to engage in commercial and economic activities issued by the territorial public health care institution confirming that the enterprise (its branches) is allowed to engage in pharmaceutical activities; 4.
  18. a certificate in the form established by the State Medicine Control Service that the premises and equipment of the enterprise (its branches) are adequate for pharmaceutical activities; 4.
  19. a copy of the permit to manage pharmaceutical activities, application by a pharmaceutical chemist to register him/her as the manager of pharmaceutical activities at the indicated enterprise (its branch), and a pledge to notify the Ministry of Health Care within a period of 10 days about the cancellation of the labour contract; 4.
  20. copies of graduation diplomas of pharmaceutical chemists or pharmaceutical technicians (owners or shareholders) as well as copies of the founding agreement (memorandum of association) of the enterprise so that Article 11

(2)of the Law on Pharmaceutical Activities of the Republic of Lithuania is complied with in case the activities specified in points 10.2 and 10.3 of the present Regulations are to be conducted; 4.
  1. a list of branches engaged in pharmaceutical activities indicating their addresses, telephone numbers, full names of specialists who manage pharmaceutical activities there, numbers of their permits to manage pharmaceutical activities; 4.
  2. a payment order with bank requisites or receipt confirming the payment of stamp tax (submitted after the decision to issue a licence is adopted).
  3. To re-register a licence, an enterprise shall submit to the Ministry of Health Care the documents indicated in points 4.1, 4.4, 4.9 and 4.10 of the present Regulations.
  4. If an enterprise wishes to conduct pharmaceutical activities in a new branch, its licence shall be supplemented after submitting the documents indicated in points 4.1, 4.3-4.7 of the present Regulations.
  5. If there are changes in the address of premises where the enterprise conducts pharmaceutical activities, the licence shall be supplemented after submitting the documents indicated in points 4.1, 4.5 and 4.6 of the present Regulations. Procedure and Terms of Document Examination
  6. The Ministry of Health Care shall examine the submitted documents and make a decision within a period of 30 days from the date of receipt of the documents. Licence Taxes
  7. Stamp tax shall be collected for the issue and re-registration of licences in accordance with the procedure prescribed by the Law on Stamp Tax of the Republic of Lithuania and resolutions of the Government of the Republic of Lithuania. Types of Licences
  8. Licences shall be issued to engage in the following pharmaceutical activities: 10.
  9. to conduct research in and produce medicines and medicinal substances; 10.
  10. to produce medicines and conduct retail trade in medicines and medicinal substances; 10.
  11. to conduct retail trade in medicines and medicinal substances; 10.
  12. to conduct wholesale trade in medicines and medicinal substances; 10.
  13. to supply information about medicines.
  14. Licences shall be issued for an unlimited period of time and shall be re-registered every 10 years. Form of Licences
  15. The form of licences shall be established by the Ministry of Health Care. The licence shall specify: 12.
  16. name and number of licence; 12.
  17. requisites of licence holder (name and code of enterprise, address of its registered office and locations of activities); 12.
  18. pharmaceutical activity for which a licence is issued; 12.
  19. date of issue; 12.
  20. date of re-registration; 12.
  21. institution that issues licences; 12.
  22. full name of the specialist who manages the pharmaceutical activities of the enterprise; 12.
  23. addresses of licence holder's branches having the right to engage in pharmaceutical activities.
  24. The Ministry of Health Care shall keep the Register of Licences. The register shall specify: 13.
  25. licence number; 13.
  26. requisites of licence holder (name and code of enterprise, address of its registered office and locations of activities); 13.
  27. pharmaceutical activity for which a licence is issued; 13.
  28. date of issue; 13.
  29. date of re-registration; 13.
  30. date of suspension of licence; 13.
  31. date of annulment of suspension; 13.
  32. date of withdrawal of licence; 13.
  33. full name of the specialist who manages the pharmaceutical activities of the enterprise, category of qualification, number of permit to engage in pharmaceutical activities; 13.
  34. addresses of licence holder's branches having the right to engage in pharmaceutical activities.
  35. The Ministry of Health Care that has issued, re-registered, suspended, revoked such suspension or revoked a licence shall publish a notice in “Valstybės Žinios”. The notice shall indicate: 14.
  36. licence number; 14.
  37. name of the enterprise, its code and address; 14.
  38. activities for which a licence is issued; 14.
  39. date of issue, re-registration, suspension, annulment of suspension, and withdrawal of licence. Refusal to Issue or Re-Register Licences
  40. Licences shall not be issued or re-registered if: 15.
  41. not all documents required for issuing or re-registering a licence are submitted or they are not drawn up as required; 15.
  42. submitted date is misleading; 15.
  43. supervising authorities submit information in writing about the violations of conditions for licensed activities.
  44. In case of refusal to issue or re-register a licence, the applicant shall be informed thereof in writing within a period of 30 days from the date of receipt of the documents and reasons for such refusal shall be indicated. Conditions for Licensed Activities
  45. Licensed activities shall be carried out in accordance with the present Regulations, Law on Pharmaceutical Activities of the Republic of Lithuanian, resolutions of the Government of the Republic of Lithuania, other Lithuanian laws and legal acts regulating the activities of enterprises, health-related activities and tax payment.
  46. Supervising authorities shall immediately inform in writing the institution that issues licences about the violations of conditions for licensed activities discovered in enterprises.
  47. Enterprises with licences shall have the right to engage in the activities specified in the licence only in locations indicated therein.
  48. The original licence shall be kept at the registered office of the enterprise. Other branches indicated in the licence and engaged in the activities specified therein shall keep a copy of the licence.
  49. If a licence holder loses the licence and publishes a notice in the national press that it is no longer valid, it shall receive a duplicate from the Ministry of Health Care.
  50. In case of change of the specialist who manages pharmaceutical activities, the enterprise shall notify the institution that issues licences thereof and submit a document indicated in point 4.7 of the present Regulations so that relevant supplements are introduced to the licence. Rights of Licence Holders
  51. Enterprises with a licence to engage in pharmaceutical activities shall have the following rights: 23.
  52. to conduct pharmaceutical activities specified in the licence; 23.
  53. to demand explanation in case of suspension and withdrawal of the licence or refusal to issue or re-register it; 23.
  54. to appeal to the court in accordance with the established procedure against the decisions of the Ministry of Health Care to suspend, refuse to issue or re-register the licence. Procedure of Suspension and Withdrawal of Licences
  55. Licences shall be suspended if: 24.
  56. conditions for licensed activities are violated; 24.
  57. it is established that the submitted data is misleading; 24.
  58. licence holder does not make payments in due time to the national (municipal) budget of the Republic of Lithuania, the budget of the State Social Insurance Fund or other state funds administered by the State Tax Inspectorate.
  59. The Ministry of Health Care shall inform the licence holder about the decision to suspend the licence within 10 days after it is made; it will also indicate the reasons for suspending the licence and the period given to eliminate violations.
  60. If the indicated violations are eliminated within a given period, the suspension of the licence shall be revoked by decision of the Ministry of Health Care.
  61. Licences shall be revoked if: 27.
  62. licence holder terminates its licensed activities and submits a request to the Ministry of Health Care to revoke the licence; 27.
  63. an enterprise the licence of which has been suspended does not eliminate the violations of conditions for licensed activities; 27.
  64. an enterprise is under liquidation, bankruptcy procedure or reorganisation; 27.
  65. licence holder does not re-register the licence in due time.
  66. The Ministry of Health Care shall inform the licence holder about the decision to revoke the licence within 10 days after it is made and reasons for revoking the licence shall be indicated.
  67. An enterprise the licence of which has been revoked shall be issued a new licence not earlier that 6 months after the date of its withdrawal.
  68. After the licence is revoked, the enterprise shall return the original licence to the Ministry of Health Care within a period of 10 days from the date of receipt of the notice.

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