Regulations for the Import into the Republic of Belarus, Registration, Storage and Distribution of Medicines, Medical Purpose Items and Equipment Coming as Foreign Gratuitous Aid  

Brought into force by the enactment of the Ministry of Health of the Republic of Belarus No. 7 of 15 March 2005

1.     The Regulations for the import into the Republic of Belarus, registration, storage and distribution of medicines, medical purpose items and equipment coming as foreign gratuitous aid (hereinafter referred to as the Regulations) establish uniform routine and procedures for the import into the Republic of Belarus, registration, storage and distribution of medicines, medical purpose items and equipment coming as foreign gratuitous aid (hereinafter – foreign gratuitous aid).

2.     Medicines, medical purpose items and equipment are imported into the Republic of Belarus as foreign gratuitous aid provided the Ministry of Health of the Republic of Belarus has granted its approval to the recipient of the foreign gratuitous aid:

- organisations and self-employed entrepreneurs – for the purposes of medical assistance;

- individuals – for personal needs. 

3.     Arrangements are made by the Republican Unitary Enterprise “Medical Care Expertise and Tests Centre” to organise and carry out the examination of documents for the purposes of having imports of foreign gratuitous aid approved.

4.     To be granted approval for the import of foreign gratuitous aid used for medical assistance, organisations and self-employed entrepreneurs (hereinafter referred to as applicants) submit the original and one copy of the following documents:

4.1 in respect of medicines:

·  request for approval of the import of medicines coming as foreign gratuitous aid;

·  agreement or donative letter for foreign gratuitous aid;

·  specification indicating items (trade name and international generic name), country of manufacture, manufacturer, make, quantity, use-by date, value of imported medicines (a specification should be authenticated by the signature of an applicant being a self-employed entrepreneur or head of the orgranisation);

·  applicant’s certificate of state registration;

·  distribution scheme listing corporate bodies and self-employed entrepreneurs that are specifically permitted (licensed) to medical activities and receive foreign gratuitous aid from the applicant to provide medical aid to citizens;

·  documents certifying the quality of each series (batch) of imported medicines;

4.2 in respect of medical purpose items and equipment:

·  request for approval of the import of medical purpose items and equipment coming as foreign gratuitous aid;

·  agreement or donative letter for foreign gratuitous aid;

·  specification indicating items, country of manufacture, manufacturer, quantity, year of manufacture, use-by date (for medical purpose items), value of imported medical purpose items and equipment (a specification should be authenticated by the signature of an applicant being a self-employed entrepreneur or head of the orgranisation);

·  applicant’s certificate of state registration;

·  distribution scheme listing corporate bodies and self-employed entrepreneurs that are specifically permitted (licensed) to medical activities and receive foreign gratuitous aid from the applicant to provide medical aid to citizens;

·  manufacturer’s certificate or operating manual;

·  documents certifying the quality of medical purpose items and equipment.

5. To be granted approval for the import of foreign gratuitous aid used for personal needs, individuals submit the original and one copy of the following documents

5.1 in respect of medicines:

·  request for approval of the import of medicines coming as foreign gratuitous aid;

·  donative letter for foreign gratuitous aid indicating items (trade name and international generic name), country of manufacture, manufacturer, make, quantity, use-by date, value of imported medicines;

·  individual’s passport;

·  report by a medical officer in charge or health care body confirming that an individual recipient of foreign gratuitous aid requires the medicines and indicating the recommended quantity for the course of therapy;

5.2 in respect of medical purpose items and equipment:

·  request for approval of the import of medical purpose items and equipment;

·  donative letter for foreign gratuitous aid indicating items, country of manufacture, manufacturer, quantity, year of manufacture, use-by date (for medical purpose items), value of imported medical purpose items and equipment;

·  individual’s passport;

·  report by a medical officer in charge or health care body confirming that an individual recipient of foreign gratuitous aid requires the medical purpose items and equipment;

·  manufacturer’s certificate or operating manual.

6.     The original documents listed under Articles 4 and 5 of the Regulations shall be returned to the recipients of foreign gratuitous aid, copies shall be kept by the Republican Unitary Enterprise “Medical Care Expertise and Tests Centre”.

7.     The documents submitted in foreign languages shall be translated into Russian or Belarusian and duly authenticated.

8.     Medicines coming as foreign gratuitous aid shall have remaining period of validity of:

not less than two years for five years valid medicines;

not less than one year for under five years valid medicines and sterile medical purpose items.

The quantity of medicines coming as foreign gratuitous aid shall not fall short of the needs for the course of therapy.

The medical equipment coming to the Republic of Belarus as foreign gratuitous aid shall be in service not more than five years from the year of manufacture.

As decided by the Ministry of Health of the Republic of Belarus authorized to grant approval of the import of medicines, medical purpose items and equipment coming as foreign gratuitous aid, timing specified in clauses 1 and 3 of this Article can be subject to change.

9.     The marking on each packing container or box shall include trade and international generic name of the item, series number, make, presence of active agents, manufacturer, number of pieces, conditions of storage and use-by date.

Medicines shall be packed pursuant to the international cargo rules and issued a packing sheet detailing the contents of each numbered box and indicating trade and international generic name of the item, make, quantity, series number, volume, weight and conditions of storage. Medicines shall not be mixed with other items in the same pack.

10. It is unauthorized to import into the Republic of Belarus foreign gratuitous aid in the form of medicines included into the republican list of narcotic drugs, psychotropic substances and their precourses subject to the state controls in the Republic of Belarus, enacted by the Ministry of Health of the Republic of Belarus No. 26 of 28 May 2003.

11. Based on the examination of the documents, the Ministry of Health of the Republic of Belarus grants approval for the import of foreign gratuitous aid.

The approval is expressed through a permissive dated record “Import permitted” put on the specification or donative letter and authenticated by the Minister of Health’s signature or authorized Deputy Minister’s signature and official seal.

The items on the specification or donative letter unauthorized for the import into the Republic of Belarus shall be crossed out and the permissive record shall include “excluding items No. _____”.

12. The approval (denial) of the import of foreign gratuitous aid shall be granted within not more than ten days of receipt of all required documents from the recipient of foreign gratuitous aid, as envisaged by these Regulations.

13. The approval of the import of foreign gratuitous aid may be denied in the event that the submitted documents do not meet requirements of the national legislation or these Regulations.

14. Following the granting of approval, one copy shall be returned to the recipient of foreign gratuitous aid, the second copy shall be kept by the Republican Unitary Enterprise “Medical Care Expertise and Tests Centre”.

15. The approval of the import of foreign gratuitous aid is effective from the date of issuance until the Department for Humanitarian Activities has issued a registration certificate for foreign gratuitous aid, but not more than three months after the approval has been granted.

16. In the event that a recipient of foreign gratuitous aid disagrees with the decision of the Ministry of Health of the Republic of Belarus, he or she has a right to appeal by way of relevant legal routine.