ORDER OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF MOLDOVA

of April 26, 2024 No. 395

About approval of the Provision on authorization of import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova

According to h (7) to Art. 11 of the Law No. 1456/1993 on pharmaceutical activities, the item 8, the subitem 6) of the item d) Regulations on the organization and functioning of the Agency on drugs and medical products approved by the Order of the Government No. 71/2013, of item 9 of the Order of the Government No. 148/2021 about the organization and functioning of the Ministry of Health, the Order of the Ministry of Health No. 739/2012 on regulation of authorization of medicines for the person and approval of post-registration changes I ORDER:

1. Approve the Provision on authorization of import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova, according to this order.

2. Declare invalid the Order of the Minister of Health No. 559/2017 on the Provision on authorization of import of medicines, other pharmaceutical medicines, parapharmaceutics and not authorized medicinal raw materials to the Republic of Moldova.

3. To impose control of execution of this order on Mr. Alexander GASNASH, the state secretary.

Appendix

to the Order of the Ministry of Health of the Republic of Moldova of April 26, 2024 No. 395

Provision on authorization of import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova

Chapter I General provisions

1. The provision on authorization of import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova (further - the Provision) is developed according to provisions of the h. (7) Art. 11 of the Law No. 1456/1993 on pharmaceutical activities.

2. This Provision establishes the basic principles on authorization of import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova, the list of the obligatory documents submitted to the Agency on drugs and medical products (further - ALMI), procedure for decision making about authorization.

3. The provision is subject to execution by all economic agents (further - the applicant) submitting the application for import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova.

Chapter II the Basic principles on authorization of import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova

4. ALMI makes the decision on authorization of import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova.

5. The decision on authorization of import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova is accepted on commission session on authorization of import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova (further - the Commission) by a majority vote and affirms the CEO of ALMI.

6. The decision on approval of import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova is issued only in case of representation by the applicant of the obligatory documentation established by this Provision and in one of the following cases:

a) Availability of emergency situation in the field of public health - the national or international situation confirmed with the act of availability of inevitable risk or the confirmed distribution of pathogens, toxins, chemicals or radiation or any other factors, in particular, of epidemics and pandemics which can do harm to public health. ALMI can temporarily issue the import permit of the unregistered medicine on the territory of the Republic of Moldova; or

b) Lack of analogs or substitutes in the pharmaceutical market - in case of lack of medicine with the same international name (the same dose and pharmaceutical form) or medicine alternatives (the active agent relating to the same group of automatic telephone exchange - the Anatomo-terapevtichesky chemical code), can temporarily issue to ALMI the import permit of the unregistered medicine on the territory of the Republic of Moldova but permitted in country of source in the context of Art. 11 of h (7) the Law 1456/1993.

7. In addition to requirements of Item 6 of this provision import of not authorized raw materials to the Republic of Moldova is allowed in the following cases:

a) medicine development;

b) preparation of medicines in drugstores with production function.

8. The decision on approval of import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova is confirmed by issue authorization for import from ALMI according to provisions of the Law No. 160/2011 on regulation entrepreneurial activities by permission.

Chapter III the Procedure for authorization of import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova

9. For receipt of authorization for import of medicines and/or not authorized medicinal raw materials to the Republic of Moldova the applicant submits the following documents (file) by means of the government electronic SIA GEAP platform:

1) in case of the request for authorization of import of not authorized medicines according to regulations of Item 662 of the Order of the Minister of Health No. 739/2012 on regulation of authorization of medicines for the person and approval of post-registration changes:

a) the statement according to the sample given in appendix No. 1 to this Provision;

b) purchase and sale agreement of medicines;

c) the technical and price specification of medicines according to appendix No. 1 to this Provision (it is represented in the .pdf or .excel format);

d) The declaration of conformity - the act (declaration) which the applicant under the responsibility certifies reliability and compliance of the submitted documents;

e) the authentic and objective reasoned letter confirming need of presence of not authorized medicines in the Republic of Moldova;

2) in case of the request for authorization for import of the medicines and/or medicinal raw materials intended for placement in the market of the Republic of Moldova for retail sale:

a) the statement according to the sample given in appendix No. 1 to this Provision;

b) purchase and sale agreement of medicines and/or medicinal raw materials;

c) the technical and price specification of medicines and/or medicinal raw materials according to appendix No. 2 to this Provision (it is represented in the .pdf or .excel format);

d) statements from price catalogs of countries of source and the countries in which medicine is authorized (really for medicines);

e) the authentic and objective letter with the argumentation confirming need of presence of not authorized medicines in the Republic of Moldova;

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