ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of October 3, 2018 No. 944

About approval of the Regulations on ethical standards of promotion of drugs

For the purpose of ensuring rational use of drugs and consumer protection, and also based on part (1-1) articles 22 of the Law No. 1409/1997 on the drugs Government DECIDES:

1. Approve Regulations on ethical standards of promotion of drugs it (is applied).

2. To impose control of execution of this resolution on the Agency on drugs and medical products and on the National agency of public health.

3. This resolution becomes effective from the date of publication, except for in a month Items 62 and 65 of the Provision specified in Item 1, which become effective in 6-month time from the date of publication.

Approved by the Order of the Government of the Republic of Moldova of October 3, 2018 No. 944

Regulations on ethical standards of promotion of drugs

This Provision is transposition of Article 1, of Sections VIII and VIIIa of the Directive 2001/83/EU of the European Parliament and Council of the November 6, 2001 establishing the Code of Community about medicines for the person published in the Official magazine of the European Union by L 311 of November 28, 2001 and b letters) and c) articles 2, of the article 3, of article 4 of the Directive 2006/114/EU of the European Parliament and Council of December 12, 2006 about the misleading and comparative advertizing (the text important for EES) published in the Official magazine of the European Union by L 376 of December 27, 2006.

Chapter I General provisions, determinations, scope, regulation

Part 1 General provisions

1. The regulations on ethical standards of promotion of drugs (further - the Provision) regulate actions for respect for ethical standards and responsibility in case of promotion that provides observance of social and economic consumer interests.

2. The agency on drugs and medical products (further - the Agency) is competent authority according to notifications and promotional materials, and also any other forms of advertizing of drugs for the person.

3. The national agency of public health exercises the state control of compliance with law in the field of advertizing and promotion of drugs for the person according to provisions of the Law No. 131/2012 on the state control of business activity.

4. Advertizing of drugs can be intended for qualified persons in health sector or for the general public.

5. The certificate holder of registration of medicine or the physical person or legal entity authorized by the owner to represent it in the relations with the Agency, has the following obligations:

To store 1) available within 3 years or to transfer to the Agency sample of all promotional materials of drugs released on own initiative together with the declaration specifying persons for whom it is intended method of informing and date of the first informing;

2) to guarantee that the promotional materials developed for the advanced medicines correspond to legislation provisions in the field of informing the public, to provide rather detailed information, it is accurate and legible to give to the reader the chance to constitute the correct opinion concerning efficiency, safety and method of acceptance of medicine;

3) to make sure that his medical representatives are fully informed and fulfill lawful duties;

To provide 4) to the National agency of public health, on its request, the necessary information and obligatory documents relating to promotion of medicines according to the conditions provided by the Law No. 131/2012 on the state control of business activity;

5) to guarantee timely and complete execution of the decisions made by the National agency of public health.

6. The certificate holder of registration of medicine or its legal representative shall provide that persons, representatives to write out medicines, were without delay and in full informed on any important or relevant change of the available information on the medicine used in advertizing campaign.

7. Owing to the urgent restriction caused by changes from the point of view of safety or change of effective periods of the registration certificate of medicine for the same reasons, persons responsible for advertizing campaigns shall take all necessary measures that the promotional materials following these changes reflected new form in accuracy and represented possible distinctions in relevant and accurate manner.

Part 2 Determinations

8. For the purposes of this provision the provided terms and the used determinations have the following value:

the supplier of advertizing - person constituting source or object of advertisement for production, placement and the subsequent distribution of advertizing;

MNN - the international non-proprietary name recommended by the World Health Organization;

scientific and practical action - the planned meeting intended for persons having the right to write out or issue drugs organized and/or sponsored by the pharmaceutical companies, their branches and representations, and also other representatives them the organizations, including the congresses, conferences, seminars, symposiums, meetings on planning, training, rates, round tables (each referred to as "action") which have the scientific and/or professional purpose;

the promotional material - any means used for the purpose of stimulation of appointment, distribution, release, realization or consumption of drugs;

the training material - any means or the device which is relevant for medical practice has the educational purpose (books, specialized medical magazines, managements on medical practice, etc.) and does not contain the name or brand of the pharmaceutical company and/or the commercial name of certain medicine;

information material - any means or the device which is relevant for medical practice and is intended for informing the qualified persons having the right to write out or release drugs, according to the short description of product characteristics and/or conditions of writing out and leave of medicine;

medicine OTS (Over The Counter) - drugs which can be released without medical instruction;

the drugs Rx - drugs which are released according to the medical instruction;

advertizing sample (further - sample) - the limited quantity of medicine provided to free of charge qualified persons they got acquainted with product;

skilled persons - workers of health sector (doctors, druggists, laboratory assistants-druggists, nurses);

promotion - any activities organized, which are carried out or financed by the pharmaceutical company (or with its permission) which promote the instruction, distribution, leave or consumption of drugs;

advertizing of drugs - distribution by direct or indirect methods of information of the public, and also any other type of activity directed to stimulation of the instruction, distribution, leave or consumption of drugs;

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