of April 22, 2019 No. KR DSM-45
About approval of Rules of production of medicines and medical products
According to article 68 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" PRIKAZYVAYU:
1. Approve the enclosed Rules of production of medicines and medical products.
2. To provide to committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:
1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;
2) within ten calendar days from the date of state registration of this order the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "Institute of the legislation and legal information of the Republic of Kazakhstan" the Ministries of Justice of the Republic of Kazakhstan for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;
3) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;
4) within ten working days after state registration of this order submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2) and 3) of this Item.
3. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.
No. KR DSM-45 are approved by the Order of the Minister of Health of the Republic of Kazakhstan of April 22, 2019
1. These rules of production of medicines and medical products (further - Rules) determine procedure for production of medicines and medical products.
2. Production of medicines and medical products is performed by the subjects in the sphere of drug circulation, medical products having the corresponding license for production of medicines and medical products.
3. In these rules the following concepts are used:
1) production of medicines - the pharmaceutical activities connected with production of medicines in drugstores with acquisition of pharmaceutical substances (active pharmaceutical substances) for pharmaceutical application, storage, quality control, registration and realization of the made medicines;
2) production of medical products - the pharmaceutical activities connected with production of medical products in drugstores, shops of medical products and shops of optics;
3) proper production practice - the national standard in the sphere of drug circulation and medical products establishing requirements to production organization, production process and monitoring procedure in case of production of medicines and medical products;
4) sterile medicines - the medicines in certain dosage form which underwent process of sterilization on lack of live organisms.
4. Production of medicines and medical products is performed on the basis of the medicines registered in the Republic of Kazakhstan, except for medicinal substances, made in the conditions of proper production practice.
5. Manufacturing techniques of the medicines and medical products made in the conditions of drugstore of shop of medical products and shop of optics are performed according to requirements of general clauses of the State pharmacopeia of the Republic of Kazakhstan, individual pharmakopeyny clauses, foreign pharmacopeias, acknowledged acting in the territory of the Republic of Kazakhstan, the regulating documents approved by authorized body in the field of health care.
6. In the medical organizations which do not have as a part of drugstore with the right of production of medicines production and (or) packing of medicines, restacking of medicines from one packaging in another, replacement of labels is not allowed.
7. Medicines are made taking into account the following conditions:
1) observance of rules of writing out of recipes according to the Rules of writing out, accounting and storage of recipes approved by the order of the Minister of health and social development of the Republic of Kazakhstan of May 22, 2015 No. 373 (it is registered in the Register of state registration of regulatory legal acts at No. 11465), compliance of the registered doses to age of the patient, regulations of one-time leave, compatibility of the ingredients which are part of medicine;
2) observance of manufacturing techniques of medicines;
3) providing medicine with the corresponding marking and packaging;
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
Database include more 38000 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.
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.