Document from CIS Legislation database © 2003-2025 SojuzPravoInform LLC

ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of August 28, 2024 No. 599

About approval of Rules of proper pharmaceutical practice

Based on part (4) article 3 of the Law No. 1456/1993 on pharmaceutical activities (repeated publication: The official monitor of the Republic of Moldova, 2005, Art. No. 59-61, 200), with subsequent changes, DECIDES: the Government

1. Approve:

1.1. Rules of proper pharmaceutical practice, according to appendix No. 1;

1.2. Sample of the Certificate of conformity to proper pharmaceutical practice, according to appendix No. 2.

2. Determine that:

2.1. the term of implementation of Rules of proper pharmaceutical practice constitutes 3 years from the effective date of this resolution;

2.2. the pharmaceutical organizations having the certificates of accreditation issued by the National agency on public health valid at the time of the beginning of certification process on compliance to proper pharmaceutical practice continue the activities based on the license and the certificate of accreditation, but no later than the term specified in subitem 2.1.;

2.3. certification on compliance to proper practice will be performed taking into account expiration of the certificates of accreditation issued by the National agency on public health;

2.4. newly created pharmaceutical organizations shall be certified according to proper pharmaceutical practice within 6 months from the date of receipt of the license;

2.5. licensed pharmaceutical organizations which at the time of the beginning of certification process on compliance to proper pharmaceutical practice have no the certificate of accreditation issued by the National agency on public health or the term of its action expired, certifications within 6 months from the date of entry into force of the Regulations on the procedure of certification on compliance to proper pharmaceutical practice of pharmaceutical organizations approved by the Ministry of Health are subject;

2.6. effective period of the Certificate of conformity to proper pharmaceutical practice constitutes 5 years from the date of check. Term can be reduced due to use of the principles of risk management in regulatory activities;

2.7. the final term of introduction of requirements for collection at the population of medicines of the expired, unused or damaged medicines is on January 1, 2025.

3. To pharmaceutical organizations:

3.1. provide implementation of Rules of proper pharmaceutical practice in the terms specified in Item 2;

3.2. within one month from the date of entry into force of this resolution to provide to the Agency on drugs and medical products information on expiry date of the certificate of accreditation issued by the National agency on public health;

3.3. in 2 months prior to expiration of the certificate of accreditation to represent to the Agency on drugs and medical products the request for check planning;

3.4. in case of lack of certification on compliance to proper pharmaceutical practice at the scheduled time, the economic agent stops activities of pharmaceutical organization before receipt of the Certificate of conformity to proper pharmaceutical practice.

4. To the agency on drugs and medical products:

4.1. issue the certificate of conformity to proper pharmaceutical practice to pharmaceutical organizations, the organization and which activities correspond to Rules of proper pharmaceutical practice;

4.2. make changes to the regulations according to provisions of this resolution.

5. To the Ministry of Health:

5.1. in 3-month time from the date of entry into force of this resolution to develop and approve Regulations on the procedure of certification on compliance to proper pharmaceutical practice of pharmaceutical organizations;

5.2. in 6-month time from the effective date of this resolution to make according to it changes to the regulations.

Prime Minister

Doreen Rechan

 

Countersigns:

Minister of Health 

 

Nemerenko is scarlet

Appendix No. 1

to the Order of the Government of the Republic of Moldova of August 28, 2024 No. 599

Rules of proper pharmaceutical practice

Chapter I General provisions

1. These rules of proper pharmaceutical practice (Good Pharmacy Practice – GPP) (further – the Rules GPP) contain the rules applied in pharmaceutical organizations for the purpose of ensuring provision by pharmaceutical personnel of the corresponding, effective and oriented to requirements patients of services.

2. These rules of GPP establish requirements to the organization of quality management system when rendering pharmaceutical services to the population which provides provision by druggists of services of proper quality, the effective and directed to achievement of advantage for health patients.

3. These rules of GPP extend to all types of drugstores, and also their branches, irrespective of type of property and form of business.

4. The GPP concepts used in these rules have the following values:

4.1. self-treatment – practice of use of one or several medicines on own initiative or on the advice of other person, without consultation with the doctor;

4.2. the head of pharmaceutical organization – the chief druggist / chief of branch who will organize also coordinates professional activity of pharmaceutical organization and bears responsibility for financial and economic, administrative and economic activity;

Warning!!!

This is not a full text of document! Document shown in Demo mode!

If you have active License, please Login, or get License for Full Access.

With Full access you can get: full text of document, original text of document in Russian, attachments (if exist) and see History and Statistics of your work.

Get License for Full Access Now

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

Effectively work with search system

Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system

Get help

If you cannot find the required document, or you do not know where to begin, go to Help section.

In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.

You also may open the section Frequently asked questions. This section provides answers to questions set by users.

Search engine created by SoyuzPravoInform LLC.