LAW OF THE REPUBLIC OF MOLDOVA

of February 20, 2025 No. 25

About modification of some regulations (The law on the state control No. 131/2012 and the accompanying industry laws)

The Parliament adopts this organic law.

Art. I. - In the Law on pharmaceutical activities No. 1456/1993 (repeated publication: The official monitor of the Republic of Moldova, 2005, Art. No. 59-61, 200), with subsequent changes to make the following changes:

1. In part (Article 8 of the word "and veterinary science" to exclude 1).

2. Parts (2) and (Article 14-2 to state 3) in the following edition:

"(2) In day of registration of a statement and the documents established by this Article for obtaining or renewal of the license, the Agency on drugs and medical products appoints carrying out control visit for check of compliance to the established requirements of conditions of activities of the applicant, including activities with use of narcotic and/or psychotropic substances and their precursors.

(3) Within no more than 10 working days from the moment of registration of a statement the Agency on drugs and medical products constitutes the protocol of control by results of carried out according to part (2) checks. If the specified agency did not execute control visit or did not issue the protocol of control within 10 working days from the moment of registration of a statement, the principle of acquiescence is applied.".

3. To state the name of Chapter III in the following edition:

"Chapter III STATE CONTROL OF QUALITY of DRUGS AND MEDICAL PRODUCTS AND OF PHARMACEUTICAL ACTIVITIES".

4. Parts (1) and (Article 15 to state 3) in the following edition:

"(1) the State control of quality of drugs, pharmaceutical products, parapharmaceutical and medical products is performed by the Agency on drugs and medical products.";

"(3) the State control of pharmaceutical activities of physical persons and legal entities irrespective of type of property and form of business is performed by the Agency on drugs and medical products according to provisions of the Law on the state control No. 131/2012.".

5. Add the law with Article 16-1 of the following content:

"Article 16-1. The measures applied by results of the state control of quality of drugs and medical products and of pharmaceutical activities

In case of identification during implementation of the state control of violations of the law the drugs and medical products inspector of the Agency issues instructions and/or recommendations, applies sanctions and/or rationing arrangements in the limits provided by this law and the Law on the state control No. 131/2012.".

6. Part (Article 18 to state 4) in the following edition:

"(The Agency on drugs and medical products stops 4) or prohibits production, import and realization in the Republic of Moldova of drugs, narcotic substances and parapharmaceutical products in case of their discrepancy to requirements of the pharmacopeia approved at the national level or the registration file on medicine, and also in case of identification and establishment of their harmful effects on human health according to provisions of the Law on the state control No. 131/2012 and the requirements established by the order of the Minister of Health which are published in the Official monitor of the Republic of Moldova.".

7. Recognize Article 26 invalid.

Art. II. - In the Law on environmental protection No. 1515/1993 (Monitor of Parliament of the Republic of Moldova, 1993, No. 10, of the Art. 283), with subsequent changes, to make the following changes:

1. In part (4) Article 26 of the word "The law on the state control of business activity No. 131 of June 8, 2012." shall be replaced with words "The law on the state control No. 131/2012.".

2. In Article 27:

in Item d) parts (1) words "Law on the state control of business activity No. 131/2012;" shall be replaced with words "The law on the state control No. 131/2012;";

part (1-1) to state in the following edition:

"(1-1) Activities stop in parts or in full on the basis of the actions and measures provided by part (1), in case of identification during control heavy, with exceeding of the most admissible concentration of pollutants, violations which will obviously and directly entail environmental pollution and as a result will cause significant damage to the environment and health of the population and which cannot be eliminated without suspension of operations. The actions and measures provided by part (1), are applied according to provisions of the Law on the state control No. 131/2012.".

Art. III. - In the Law on fire safety No. 267/1994 (Official monitor of the Republic of Moldova, 1995, Art. No. 15-16, 144), with subsequent changes, to make the following changes:

1. In Item f) Article 23 of the word of "The law on the state control of business activity No. 131/2012" shall be replaced with words "The law on the state control No. 131/2012".

2. In Article 24:

in Item f) parts (1) words "Law on the state control of business activity No. 131/2012;" shall be replaced with words "The law on the state control No. 131/2012;";

part (to state 2) in the following edition:

"(2) Activities or works on construction and reconstruction of objects stop in parts or in full on the basis of the actions and measures provided by part (1), in case of identification during control of heavy violations, which obviously and directly lead to emergence of the fire, creating direct threat of life and to human health and threat of destruction of material values in considerable sizes and which at the same time cannot be eliminated without suspension of operations. The actions and measures provided by part (1), are applied according to provisions of the Law on the state control No. 131/2012.".

Art. IV. - In the Law on civil protection No. 271/1994 (Official monitor of the Republic of Moldova, 1994, No. 20, of the Art. 231), with subsequent changes, to make the following changes:

1. In part (2) Article 20 of the word "The law on the state control of business activity No. 131/2012." shall be replaced with words "The law on the state control No. 131/2012.".

2. In Article 21:

in Item e) parts (1) words "Law on the state control of business activity No. 131/2012;" shall be replaced with words "The law on the state control No. 131/2012;";

part (to state 2) in the following edition:

"(2) Activities or works on construction and reconstruction of objects stop in parts or in full on the basis of the actions and measures provided by part (1), in case of identification during control of heavy violations, which obviously and directly lead to emergence of emergency situations, creating direct threat of life and to human health and threat of destruction (infection) of material values in considerable sizes and which at the same time cannot be eliminated without suspension of operations. The actions and measures provided by part (1), are applied according to provisions of the Law on the state control No. 131/2012.".

Art. V. - Part (5) article 53 of the Law on health protection No. 411/1995 (1995, 34, Art. 373), with subsequent changes, to state the official monitor of the Republic of Moldova to No. in the following edition:

"(5) Control of legal turnover of narcotic and psychotropic substances and their precursors, and also of activities of owners of the permissions/licenses performing the activities connected with turnover of narcotic and psychotropic substances and their precursors is planned, performed and registered the Agency on drugs and medical products according to provisions of the Law on the state control No. 131/2012 and the Law on turnover of narcotic, psychotropic substances and precursors No. 382/1999.".

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