LAW OF THE REPUBLIC OF MOLDOVA

of December 14, 2022 No. 329

About modification of some regulations

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 Article 1:

after the concept "pharmaceutical activities" to add Article with concepts of the following content:

"primary package - the reservoir or any other form of packaging which is in direct contact with medicine;

secondary package - packaging into which the primary package is inserted;";

after the concept "approval" to add Article with concept of the following content:

"the import permit of medicinal raw materials, materials, products, primary and secondary package - the permission issued by the Agency on drugs and medical products to the business entity licensed in pharmaceutical activities on production of the drugs intended for the person and preparation of the main dosage forms; the allowing document issued by the Agency on drugs and medical products for implementation of the foreign trade transactions (import) for a certain period of time and in certain limits;";

after the concept "first approval" to add Article with concepts of the following content:

"preparation of drugs - pharmaceutical activities, other than production, performed on the basis of the established formula provided by specialized literature or the recommendation of doctors, organizations or bodies of health care, implemented in the drugstores having production department;

the main medicines - the drugs made in drugstores according to the main (individual) recipes and also in the form of pharmaceutical developments according to the repeating recipes;";

after the concept "the declared purchase price" to add Article with concept of the following content:

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