Appendix A

(part I)

Provisional Order for the Registration of  Foreign  Drugs in the Republic of Belarus (effective 20 September 1993)

1. The present order applies to whole drugs, that were not previously registred in the USSR or the  Republic of Belarus.

2. Registration is carried out by the Ministry of Public Health via the  Pharmacology and Pharmaceutical Committee and regional affices. Every drug must be registred, irrespective of the amount of the medicaments, including all necessary documents with each drug form.

3. For drug registration the legal entity (firm, [company] releasing the drug or the authorised person) presents all necessary documentation in Russian for characterising the drug, including warranties for the authenticity of translation by enclosing copies of original documents appropriately attested, and identification of the source of the  translation. The submission  must include who is performing the registration procedures, the reason for  registration, the drug titles, only prior to analogues (along arbitrary form), the certificate of drug  registration  in the country of origin and  other countries in which the drug is registered. Licence

The  drug application should include a report on preclinical trials and clinical trials, normative standards for drug composition, data for quality control and methods for control. Data about  drug manufacture should prove adequacy to GMP. Information for drug use in clinical practice along with a copy of research  publications about the drug. Fife  drugs examples  and  standard.  In some cases, it may be necessary to carry out the clinical trial in order to compile the appropriate documentation.  

4. Payment for drug registration, expert review  of materials and arrangement for a clinical trials is to be in accordance with rules in the Republic of Belarus.

5. The Ministry of Public Health ensures expert review of  received materials including checking for adequacy and completeness, and comparisons to world-wide literature and the level of demands(requirements)  in the country registering and authorizing drugs for  application in its territory.

6. Depending on the results  of the expert estimations  the Ministry of Public Health, a decision about registration or rejecting  the registration, can be made. An explanation (if necessery) regarding the decision will be provided when addition trials are required.

7. Certificate of registration in the regulation form will given.

(part 2)

Application for  drug registration  in the Republic of Belarus

Company :

Country :

The commercial drug title :

in Russian:

in Latin :

General synonyms :

The presenting forms :

Compositions :

The manner of application and doses:

The manner of  prescription  ( receipt, over-the counter drugs,  only for in-patients)

List  (А, В or genaral ) 

The storage conditions: 

Expiration limitation:

Date:

Signature ( representative for registration)

Note: this form is to be completed for each drug form.

Лидер образовательных программ в области гастроэнтерологии и нутрициологии в Республике Беларусь

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© 2002 Кафедра гастроэнтерологии и нутрициологии
Дата изменения: 04.07.2004