Legislation

„Regarding the modification of the Order of the Ministry of Health of the Republic of Moldova No. 10 of January 14, 2002, „Regarding the conduct of clinical trials of medicines in the Republic of Moldova”
„Regarding the approval of the national clinical protocol ”Hypertensive emergencies”
„Regarding the modification and completion of AMDM Order No. A07.PS-01.Rg-04-112 of July 3, 2014, "Regarding the approval of administrative procedures for the registration of medical devices”
 „Regarding the recall of the medicinal product Oxytocin injectable solution 5IU/ml 1 ml N5, N5x10, manufactured by Sishui Xierkang Pharmaceutical Co. Ltd., China”
„Regarding the cancellation of the registration certificates of medicinal products”
„Regarding the tariffs for the services provided by the Medicines and Medical Devices Agency”
 „Regarding the completion of the list of certified manufacturers in accordance with the Good Manufacturing Practice (GMP) Rules, released on a batch-by-batch basis”
„Approving the criteria for assessing the legal status of medicines regarding their delivery from pharmacies”
„Regarding the procedure for marketing authorization of medicines manufactured in accordance with the Good Manufacturing Practice (GMP)”
„Regarding the modification of the qualification status for the release of human medicinal products from pharmacies”
„Regarding the main specialists of the Ministry of Health and Social Protection”
„Regarding the classification of authorized medicines in the Republic of Moldova”
„Regarding the rational use of medicines”
„Regarding the modification and completion of the Ministry of Health Order No. 60 of February 21, 2008, „Regarding the provisional Regulation of the Pharmacy Assistance Section with Medicines and Medical Devices of the Family Doctor Center and its branches”
„Regarding the recall of the product Bromhexine 4 Berlin-Chemie oral solution, 4 mg/5 ml, 60 ml N1”
„Regarding the recall of the product Ascorbic Acid sol. inj. 5% 2 ml No.10, manufactured by "Farmaco" JSC, Moldova” 
„Regarding the recall of the product Sinupret dragees N25x2, batch 0000062317”
Annex No. 1
„Regarding the modification and completion of Annex No. 2 to the Government Decision No. 348 of May 26, 2014”
„Regarding the prohibition of prescribing, preparing, and dispensing the extemporaneous form "Maturinol" and its variations”
„Regarding the approval of the terms of implementation of the Automated Information System „State Nomenclature of Medicines”SIA (NSM)” 
„Regarding the approval of the national clinical protocol ”Sudden cardiac death”
„Regarding the cancellation of the registration certificates of medicinal products”
„Regarding the withdrawal from the pharmaceutical market in the Republic of Moldova of the product "Thiogamma 600 injekt, conc./sol. perf., No. 5 and No. 10(5x2)” 
 „Regarding the submission of the EC Certificate or the EC Declaration of Conformity for the authorization of medical devices”
„Regarding the recall from the pharmaceutical market in the Republic of Moldova of the product MIG for children oral suspension 20 mg/ml 100 ml N1”
„Regarding the approval of the national clinical protocol ”Community-acquired pneumonia”
„Regarding the approval of the Regulation on the conditions for placing medical devices on the market”
„Regarding the monthly promotion of the rational use of medicines”
„Regarding the extension of the bidding period”
„Law on Medicines”
     Annex No. 1
     Annex No. 2 
     Annex No. 3
„Regarding the moratorium on state control”
  „Regarding the approval of the structure and staffing limits of the central apparatus of the Ministry of Health and Social Protection”
„Regarding the implementation of the Automated Information System „State Nomenclature of Medicines” (amended and supplemented by Government Decision No. 1011 of September 11, 2007, and Government Decision No. 491 of June 14, 2010)”
„Regarding the modification and completion of AMDM Order No. 1 of January 16, 2006, „Regarding the authorization of the import-export of medicines, other pharmaceutical and para-pharmaceutical products”
„Approving the criteria for assessing the legal status of medicines regarding their delivery from pharmacies”


„Regarding the completion of the list of certified manufacturers in accordance with the Good Manufacturing Practice (GMP) Rules, released under control series by series”
„On consumer protection”
„Regarding the cancellation of item 1 of Order No. 33 of May 29, 2009 „Regarding the cancellation of registration certificates for medicinal products”
„Approving the amendments and completions to Government Decision No. 603 of July 2, 1997”
„Health Protection Law”
„Law on Public Procurement”
Regarding the approval of the requirements for the structure of the administration instruction, primary and secondary packaging labeling of human-use medicines and their expertise”
„On the authorization of the import of unregistered pharmaceutical products in the Republic of Moldova”
„On certain measures to finalize the functionality of the Automated Information System „State Nomenclature of Medicines”
„Approving the Regulation on the approval and registration of producer prices for medicines”
„On the prohibition of receiving and preparing the prescription called "Maturinol"”
„On the modification and completion of Law No. 1409-XIII of December 17, 1997 on medicines”
„On pharmaceutical activity”
„On the approval of tables and lists of narcotic substances, psychotropic substances and their precursors subject to control"
„On the authorization of medical first aid kits in vehicle equipment”
„On the storage, record-keeping, and release of products and substances, narcotics, toxic and psychotropic substances”
„On the implementation of the automated information system „State Nomenclature of Medicines”
„Law on the regulation of entrepreneurial activity through licensing”
„On medical devices”
„Regarding the completion of the list of certified manufacturers in accordance with GMP rules, released under control series by series”
„On the application of the Nomenclature of professions and functions with harmful conditions, whose activity entitles to additional paid annual leave and reduced working hours of medical personnel”
„On establishing the annual amount of undenatured ethyl alcohol intended for use in medicine”
„On the approval of the technical requirements for premises and objectives where narcotic substances, psychotropic substances, and/or precursors are stored”
„Approving the sanitary regulation on the equipment and operation of pharmacies and pharmaceutical warehouses”
„On the approval of the Regulation on the organization of treatment in ambulatory conditions for certain chronic diseases with confirmed diagnosis in the acute stage, provided by the family physician and their team”
„On amending and supplementing the Penal Code of the Republic of Moldova”
„Law on the implementation of Title VII of the Tax Code”
"On the approval of the Regulation on the market placement conditions of in vitro diagnostic medical devices"
„Regarding the approval of the Nomenclature of professions and functions with harmful working conditions, whose activity entitles to additional paid annual leave and reduced working hours of medical personnel”
„Regarding the recall of the product Ammonia 10% 10 ml, series 011110”
„On amending and supplementing certain legislative acts”
"On amending and supplementing Law No. 1456-XII of May 25, 1993 on pharmaceutical activity”
„On the review and optimization of the regulatory framework for entrepreneurial activity”
„Regarding the approval of the List of narcotic substances containing such substances detected in illicit traffic, as well as their quantities”
„On approving the Regulation on the procurement of medicines and other medical products for the needs of the healthcare system”
„Revised and approved list of over-the-counter (OTC) medicines within the Medicines Commission (Minutes No. 1 of January 29, 2015) based on AM Order No. 21 of May 12, 2006”
„Regarding the recall of the product Corvalol, oral drops, solution 25 ml, N1”
„On amending and supplementing certain legislative acts”
„For the accession of the Republic of Moldova to the Convention on the Elaboration of a European Pharmacopoeia and the Protocol to the Convention on the Elaboration of a European Pharmacopoeia”
„On the approval of payments for the authorization of medicines,
„Law on the approval of the Nomenclature of professional training domains and specialties in higher education institutions, first cycle”
„On the quality control of pharmaceutical dosage forms prepared in pharmacies”
„On the Nomenclature of authorizations, permits, and certificates issued by central administrative authorities and their subordinate bodies to individuals and legal entities for entrepreneurial activity (extracts)”
"On approving the Regulation, structure, and staffing limit of the Medicines and Medical Devices Agency”
„Regarding the tariffs for services provided by the Medicines and Medical Devices Agency”
Regarding the approval of amendments and completions to Government Decision No. 1135 of September 18, 2003”
„Law on the evaluation and accreditation in healthcare”
„Regarding the review of DAN (Pharmacopoeial Monographs or Temporary Pharmacopoeial Monographs) for medicines containing 96% ethyl alcohol, manufactured by pharmaceutical companies in the Republic of Moldova”
„On the harmless destruction of expired medicines, counterfeit medicines, medicines with quality defects, or without proper documents (accompanying documents)”
„Regarding the procurement of pharmaceutical products and medical technical articles with public funds”
„Regarding the recall of the product Ultraproct rectal ointment, series 94085A, 02093A, 03098B, 11105A, 12112A, and 13115A”
"On approving the Regulation on the conditions for the market placement of active implantable medical devices"
„On official correspondence in electronic format”
„On the Instruction for the application of the rules of the Nomenclature of professions and functions with harmful working conditions”
„Regarding the amendment and supplementation of the Regulation on the activity of the working group for procurement”
„Regarding the recall of the product Ketotifen LPH 1 mg tablets, series 1010010146 and 1020020251”