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RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of December 21, 2021 No. 126

About complex of the preliminary technical works preceding state registration of strategically important medicines

(as amended of the Resolution of the Ministry of Health of the Republic of Belarus of 22.04.2022 No. 37)

Based on parts two and third item 4 and Item 5 of the Regulations on procedure and conditions of the implementation of state registration of strategically important medicines approved by the resolution of Council of Ministers of the Republic of Belarus of October 8, 2021 No. 570, of the paragraph of the fifth subitem 8.14-1 of Item 8 and subitem 9.1 of Item 9 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446, the Ministry of Health of the Republic of Belarus DECIDES:

1. Establish the list of the documents constituting the registration file of strategically important medicine according to appendix.

2. Approve the Instruction about procedure for carrying out complex of the preliminary technical works preceding state registration of strategically important medicines it (is applied).

3. The second Item 1 of the Instruction on procedure for carrying out complex of the preliminary technical works preceding the state registration of medicines approved by the resolution of the Ministry of Health of the Republic of Belarus of November 2, 2020 No. 93, to state part in the following edition:

"Action of this Instruction does not extend on:

complex of the examinations performed in case of registration (registration confirmation) and other procedures connected with registration of medicines within the Eurasian Economic Union;

complex of the preliminary technical works preceding state registration of medicines in the simplified procedure according to the Regulations on the simplified procedure of state registration of medicines approved by the resolution of Council of Ministers of the Republic of Belarus of April 1, 2020 No. 191;

complex of the preliminary technical works preceding state registration of strategically important medicines according to the Regulations on procedure and conditions of implementation of state registration of strategically important medicines approved by the resolution of Council of Ministers of the Republic of Belarus of October 8, 2021 No. 570.".

4. This resolution becomes effective after its official publication.

Minister

D.L.Pinevich

It is approved

Ministry of Foreign Affairs of the Republic of Belarus

 

 

Appendix

to the Resolution of the Ministry of Health of the Republic of Belarus of December 21, 2021 No. 126

The list of the documents constituting the registration file of strategically important medicine


payment order

Name of the document

Requirements to the document

1. The preliminary technical works preceding state registration of strategically important medicine (further – strategic medicine) according to the standard procedure, conditional state registration of strategic medicine

1.1

statement

the statement shall contain the following information:

the name and the location of the holder of the registration certificate, the applicant, producer (producers) of strategic medicine, including the producer performing production of ready dosage form, performing packing and (or) packaging, exercising the issuing quality control, the permission to release of strategic medicine, and also other participants of production and quality control of strategic medicine performing issue;

name and location of the producer of pharmaceutical substance;

trade name;

the international non-proprietary name ( in case of its absence – the commonly accepted (grouping) name, the scientific (chemical) name);

composition of strategic medicine ( with indication of the name and quantity operating and excipients);

dosage form with indication of dose of active ingredient (for unicomponent, two-component or three-component strategic medicine);

information on standard packaging (primary, secondary, intermediate – in the presence) with indication of quantity of doses in packaging (packing). Material of primary package, type of primary package, quantity of units of production in primary package, secondary and, in the presence, intermediate packaging, quantity of primary packages in secondary (intermediate) package (including the number of planimetric cell packagings in secondary package) information on availability of absorber of moisture, the instruction on medical application (leaf insert), completeness, information on type and quantity in packaging of bulk products is specified (in the presence);

method of application of strategic medicine (internal, external, for parenteral introduction and another);

pharmakoterapevtichesky group (code anatomo - therapeutic and chemical classification (further – the ATH code);

expiration date;

storage conditions;

security patents in the Republic of Belarus (the owner of the patent, number, date of issue, effective period);

data on the authorized person on pharmakonadzor in the Republic of Belarus;

the place of implementation of the main activities on pharmakonadzor;

location of the master file of system of pharmakonadzor;

information that the holder of the registration certificate takes the responsibility for efficiency, safety and quality of strategic medicine;

information that the holder of the registration certificate (applicant) guarantees accuracy of the information, containing in the registration file and in the statement and that the rights of the third party protected by the patent are not broken in connection with state registration of strategic medicine;

reasons: about possibility of application of state registration of strategic medicine according to the standard procedure – in case of state registration of strategic medicine according to the standard procedure; about compliance of strategic medicine to conditions for application of the procedure of conditional state registration – in case of conditional state registration of strategic medicine;

data on the contact person (in case of its availability), its location, phone.

The application is submitted on the letterhead of the applicant or holder of the registration certificate, signed by the authorized person of the applicant or the holder of the registration certificate with indication of its position of the employee, surname, own name, middle name (if that is available)

1.2

the copy of the document (documents) confirming the right to be holder of the registration certificate or the applicant (if the holder of the registration certificate does not perform production of strategic medicine) (the agreement, the license agreement, other documents)

copies of the agreement, the license agreement shall be certified by one of the parties of this agreement, the license agreement. The agreement, the license agreement constituted in foreign language shall be followed by the translation on Belarusian or Russian, to the certified one of the parties of this agreement, the license agreement.

Other documents (as a rule, the statement from the Trade register of the country of the holder of the registration certificate or the applicant, the document, confirmatory that the applicant is part of consolidation which also includes producer of medicine, the annual financial report of the holder of the registration certificate or the applicant) are presented in the form of originals or notarially attested copies of other documents. Other documents constituted in foreign language shall be followed by the translation on Belarusian or Russian (fidelity of the translation or authenticity of the signature of the translator shall be attested notarially). On documents availability of legalization or putting down of apostille is obligatory if other is not provided by international treaties of the Republic of Belarus

1.3

the document, confirmatory that the legal entity of the Republic of Belarus, the individual entrepreneur registered in the Republic of Belarus, the foreign legal entity, the foreign organization created according to the legislation of foreign states are official representatives of the holder of the registration certificate on strategic medicine

the document is presented in the form of the original document or its notarially attested copy with the translation on Belarusian or Russian (fidelity of the translation or authenticity of the signature of the translator shall be attested notarially)

1.4

the document confirming registration of medicine in the country of the holder of the registration certificate (the country of the producer) (the registration certificate or the certificate of pharmaceutical product according to the format recommended by the World Health Organization (further – WHO), the holder of the registration certificate (the country of the producer) issued by authorized body of the country on strategic medicine, or information from the official site of regulatory body on the global computer Internet confirming registration of strategic medicine (for strategic medicine of foreign production)

documents are presented in the form of originals of documents or their notarially attested copies with the translation on Belarusian or Russian (fidelity of the translation or authenticity of the signature of the translator shall be attested notarially). On documents availability of legalization or putting down of apostille is obligatory if other is not provided by international treaties of the Republic of Belarus.

In the absence of registration of strategic medicine in the country of the holder of the registration certificate (the country of the producer) the original or notarially attested copy of the certificate of pharmaceutical product with indication of absence reasons of registration or notarially attested copy of other document issued by authorized body of the country of the holder of the registration certificate (the country of the producer) explaining lack of registration with the translation on Belarusian or Russian is submitted (fidelity of the translation or authenticity of the signature of the translator shall be attested notarially). On documents availability of legalization or putting down of apostille is obligatory if other is not provided by international treaties of the Republic of Belarus.

Information from the official site of regulatory body on the global computer Internet shall be made in the form of listing of graphical representation of the screen (screenshot) of the Internet page of the official site of regulatory body on the global computer Internet and be followed by the translation on Belarusian or Russian (fidelity of the translation or authenticity of the signature of the translator shall be attested notarially). The term of production of listing shall not be more than 3 months from the date of submission of documents

1.5

the license or other document issued by authorized body of the country of origin and granting the medicine production right (for strategic medicine of foreign production)

documents are presented in the form of their notarially attested copies with the translation on Belarusian or Russian (fidelity of the translation or authenticity of the signature of the translator shall be attested notarially). On documents availability of legalization or putting down of apostille is obligatory if other is not provided by international treaties of the Republic of Belarus

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