Document from CIS Legislation database © 2003-2022 SojuzPravoInform LLC

ORDER OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF MOLDOVA

of December 9, 2014 No. 1400

About approval of Rules of proper distributor practice of drugs (GDP) for the person

(as amended on 16-12-2016)

According to the Resolution of Parliament of the Republic of Moldova No. 1352-XV of October 3, 2002 about approval of state policy in the field of drugs, the Order of the Government No. 1471 of December 24, 2007. "About approval of the Strategy of development for health care system during 2008-2017", the Order of the Government No. 71 of January 23, 2013. "About approval of the Regulations on the organization and functioning, structure and limiting manpower ceiling of the Agency on drugs and medical products", the Road map of the Agency on drugs for 2012-2014 "Reforming of system of regulation in the field of drugs and the medical equipment", approved by the Order of the Government No. 28-d of April 11, 2012, Item 9 of the Regulations on the organization and functioning of the Ministry of Health approved by the Order of the Government No. 397 of May 31, 2011 and also for the purpose of quality assurance, efficiency and safety of drugs, throughout all legal chain of distribution of drugs in the Republic of Moldova PRIKAZYVAYU:

1. Approve:

1) Rules of proper distributor practice of drugs (GDP) for the person (appendix No. 1);

2) Sample of the Certificate on compliance to Rules of proper distributor practice of drugs for the person (appendix No. 2);

3) the Sample of the Certificate on compliance to Rules of proper distributor practice of the active agents used as raw materials for drugs for the person (appendix No. 3);

2. Establish till December 31, 2016 deadline for implementation of Rules of proper distributor practice of drugs (GDP) for the person in the Republic of Moldova.

2-1. Inspections of GDP will be made based on statements of economic agents, but no later than December 31, 2016. For economic agents, distributors of medicines for the person who will not manage to implement the mentioned requirements of GDP in time specified in Item 2, but will receive positive qualification during evaluating, implementation of the mentioned regulations will be prolonged till December 31, 2017, and prolongation will be established based on decisions of the ad hoc commission created by ALMI with the assistance of representatives of MZ RM.

3. To the economic agents who are importers, distributors, drug manufacturers in the Republic of Moldova:

1) to provide implementation of Rules of proper distributor practice of drugs (NDP) for the person;

2) to suspend activities for distribution of drugs before receipt of the Certificate on compliance to Rules of proper distributor practice of drugs (GDP) for the person after the expiration specified in Item 2 of this order.

4. To the agency on drugs and medical products:

1) to issue the Certificate on compliance to Rules of proper distributor practice of drugs (GDP) for the person to the economic agents who are importers, distributors of drugs to the companies which correspond to the Rules of proper distributor practice of drugs (GDP) for the person stated in annex No. 1;

To bring 2) into accord with this order the departmental regulations.

4-1. National council by assessment and accreditation in health care system:

1) will not give assessment procedure and accreditations to the economic agents who are importers, distributors of drugs to the companies which have the Certificate on compliance to Rules of proper distributor practice of drugs (GDP) for the person;

To bring 2) into accord with this order the departmental regulations.

5. This order becomes effective from the date of publication in the Official monitor of the Republic of Moldova.

6. To impose control of execution of this order on the deputy minister Mr. Mihai Chokana.

Minister of Health

Andrey Usaty

Appendix No. 1

to the Order of the Ministry of Health of the Republic of Moldova of December 9, 2014 No. 1400

Rules of proper distributor practice of medicines (GDP) for the person

These rules of proper distributor practice of drugs (GDP) for the person (further – Rules) create basis for application of the Management of the European Commission No. 2013/C 343/01 of November 5, 2013 on proper distributor practice of drugs for the person published in the Official magazine of the European Community (JO) No. C343, 23 of November, 2013 and partially apply the provisions specified in article 85b of the Directive 2001/83/SE of the European Parliament and Council of Europe of November 6, 2001 about creation of the single code concerning drugs for the person published in the Official magazine of the European Community (JO) No. L 311, on November 28, 2001.

Section 1. Main requirements

1. Drug manufacturers apply system of quality assurance and provide accomplishment of the purposes in area of quality of drugs following Rules of proper production practice of medicines (GMP) for the person in view of the subsequent registration of drugs for the person. These conditions provide the fact that the made drugs for the subsequent distribution correspond to the ordered quality parameters.

2. Wholesale distributors of drugs also shall have the quality system which guarantees that the delivered drugs are registered in the Republic of Moldova according to the current legislation, contamination is not allowed by other products, proper turnover and storage of drugs in the safe and protected zones is performed.

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 SojuzPravoInform LLC. UI/UX design by Intelliants.