Recommendations
for submission of a set of documents to obtain a permit to import into the Russian Federation of a specific batch of unauthorized drugs for the purpose of development, research, control of safety, quality and efficacy of medicinal products, marketing authorization of a medicinal product, entry of a pharmaceutical substance in the state register of medicinal products and quality control of medicinal products.

The applicant submits to the Ministry of Health of the Russian Federation (drawn up by the applicant on paper, filled out on a printing device and as electronic copy according the form in Appendix No. 1) and attaches the following documents:

1. Application indicating the name of the medicinal product and (or) pharmaceutical substance, dosage form, dose, concentration, packaging, name of the manufacturer of the medicinal product and (or) pharmaceutical substance, country of manufacture of the medicinal product and (or) pharmaceutical substance.

2. Substantiation of the quantity of imported medicinal products and (or) pharmaceutical substances;

3. Quality certificate (analysis protocol) of imported medicinal products and (or) pharmaceutical substances issued by the manufacturer of medicinal products.

4. If there is a license to carry out activities in the field of circulation of medicinal products (pharmaceutical activities, production of medicinal products) it is submitted with the documents.

5. Contracts or other documents confirming the purpose of import, containing information on imported medicinal products and on their purchase conditions, as well as information on actual prices for imported vital and essential medicinal products and on the volumes of their import.

6. If an intermediary acts as an applicant for a permit to import medicinal products, an agreement between the exporter (importer) and the manufacturer (consumer) of the goods is attached; power of attorney.

7. Founding and registration documents of the applicant (charter, marketing authorization, certificate of registration with the tax authority)

All documents must be submitted in Russian or have a translation into Russian certified by the applicant's seal.

Annex 1.

(letterhead of the applicant)

To the Ministry of Health of the Russian Federation

Application form
to obtain a permit to import into the Russian Federation of a specific batch of unauthorized medicinal products for the purpose of development, research, safety, quality and efficacy of medicinal products, marketing authorization of a medicinal product, entry of a pharmaceutical substance in the state register of medicinal products and quality control of medicinal products.

Attached documents:

1. Explanation of the quantity of imported medicinal products and (or) pharmaceutical substances;

2. Quality certificate (analysis protocol) of imported medicinal products and (or) pharmaceutical substances issued by the manufacturer of medicinal products (it is allowed to submit a copy).

3. If there is a license to carry out activities in the field of circulation of medicinal products (pharmaceutical activities, production of medicinal products) it is submitted with the documents;

4. Contracts or other documents confirming the purpose of import, containing information on imported medicinal products and on their purchase conditions, as well as information on actual prices for imported vital and essential medicinal products and on the volumes of their import.

5. If an intermediary acts as an applicant for a permit to import medicinal products, an agreement between the exporter (importer) and the manufacturer (consumer) of the goods is attached; power of attorney.

6. Founding and registration documents of the applicant (charter, marketing authorization, certificate of registration with the tax authority).