Registered by the
Ministry of Justice of Ukraine
January 21, 2013
of December 27, 2012 No. 1130
About approval of the Procedure for carrying out confirmation of conformity of conditions of production of medicines to requirements of proper production practice
According to article 9 of the Law of Ukraine "About medicines", Item 3 of the Procedure for state registration (re-registration) of medicines approved by the resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376, the Procedure of the state quality control of medicines which are imported into Ukraine, the approved resolution of the Cabinet of Ministers of Ukraine of September 14, 2005 No. 902 (in edition of the resolution of the Cabinet of Ministers of Ukraine of August 8, 2012 to No. 793), I ORDER:
3. In accordance with the established procedure to provide to management of medicines and medical products of the Ministry of Health of Ukraine provision of this order on state registration in the Ministry of Justice of Ukraine.
4. To impose control over the implementation of this order on the deputy minister - the chief of staff of R. Bogachyov.
Approved by the Order of the Ministry of Health of Ukraine of December 27, 2012, No. 1130
1. This Procedure is developed according to the Law of Ukraine "About medicines", taking into account requirements of the Directive 2001/83/EU of the European Parliament and Council of November 06, 2001 concerning the Code of Community concerning the medicines intended for application by the person, the Directive of the Commission 2003/94/EU of October 08, 2003 which establishes the principles and rules of proper production practice concerning the medicines intended for application by the person, and the researched medicines intended for application by the person, the Collection of procedures of Community concerning inspections and exchange of information (EMA/572454/2014, 17 edition) and recommendations of documents of the international System of cooperation of pharmaceutical inspections (PIC/S) of RI 002 Requirements to the quality system of pharmaceutical inspectorates, Management RI 008 on inspection of organizations on receipt of blood and storage locations of plasma, RI of 019 Files of production site for organizations on receipt of plasma, RI of 020 Files of production site for storage locations of plasma, PI 040 PIC/S Management on classification of discrepancies of GMP.
2. In this Procedure terms are used in such values:
active pharmaceutical ingredient (medicinal substance, active ingredient, substance) (further - AFI or active ingredient) - any substance or mix of substances, held for use in medicine production, and during this use becomes its active ingredient. Such substances have pharmacological or other direct action on human body, as a part of ready forms of medicines apply them to treatment, diagnostics or prevention of disease, to change of condition, structures or physiological functions of organism, to leaving, processing and relief of symptoms;
the certified laboratory - laboratory of quality control of medicines which is certified according to the Procedure for carrying out industry certification of laboratories for quality control and safety of medicines approved by the order of the Ministry of Health of Ukraine of January 14, 2004 No. 10, registered in the Ministry of Justice of Ukraine on January 30, 2004 for No. 130/8729;
producer of medicines - subject of managing which performs at least one of production phases of medicines and has the license (permission) to production of medicines (if the last is provided by the national legal system of the country in the territory of which there are production capacities of the producer);
production of medicines - the activities connected with serial release of medicines which include everything or at least one of transactions of engineering procedure, quality control, issue of permission to release (certifications) of series, and also purchase of materials and products, storage, wholesale trade (distribution) of self-produced medicines;
the conclusion concerning confirmation of conformity of conditions of production of medicine to requirements of proper production practice (further - the Conclusion) - the document issued by Gosleksluzhboy which certifies that by results of the carried-out specialized expertize of the submitted documents the official document about compliance of production of medicines to requirements of proper production practice (Good Manufacturing Practice, GMP) issued by authorized body of the EU Member State, Great Britain or the country having the agreement on mutual recognition with the EU or with Ukraine is considered confirming compliance of conditions of production of medicines to the requirements of proper production practice existing in Ukraine;
The applicant - the subject of managing - the owner of the registration certificate (the trade license) and/or licenses for production of medicines which gives to Gosleksluzhbu personally or through the authorized person (representative) which is in Ukraine, the statement on issue of the certificate of conformity of conditions of production of medicines to requirements of proper production practice or the statement on issue of the conclusion concerning confirmation of conformity of conditions of production of medicine to requirements of proper production practice (further - the Statement) and who is responsible for reliability of provided information and documents;
sample (test) from series - the part from series which is selected thus and in such quantity which is representative for all series;
the inspector - the official Gosleksluzhby and/or the specialist who is attracted by her has the higher education on one of such specialties: the pharmacy, technology of pharmaceutical medicines, chemistry, chemical technology, biology, biotechnology, has work experience in production of medicines, quality control, management (providing) of quality or creation of medicines, and has confirmation of competence concerning proper production practice;
inspection - assessment procedure of compliance of the pharmaceutical quality system of the subject of managing and actual state of the available conditions of production of medicines and conditions of quality control to the requirements of proper production practice for the place of implementation of activities existing in Ukraine (to the location of production capacities, including zones of quality control and zones of storage under the contract (agreement));
critical violation - violation which attracts or leads to high probability of production of medicine which is harmful to the person or animal, or it which can lead to emergence of harmful remaining balance in food products of animal origin;
the laboratory analysis - the analysis of samples of medicines on compliance of indicators of quality of medicines to requirements of the specification of quality of methods of quality control of medicines or to general requirements to the medicines established by the State pharmacopeia of Ukraine in the certified laboratories;
medicine of critical risk level - medicine for which any of the following conditions is carried out: narrow therapeutic index; high toxicity; sterile product; biological medicine or difficult production process, however medicines of low risk level cannot be considered as critical even if difficult production processes are applied to their production;
medicine of high risk level - medicine which can represent risk for health of the person even in case of small quantities owing to cross contamination by products which include, but are not limited to the penicillin determined by cytotoxins and biological medicines;
medicines of low risk level - medicines, such, as: local application for therapy against acne; medicines against dandruff; antiseptic cleaners of skin; antifungal medicines for legs; products on care of skin which contains medicines; remedies from solar burns; lollipops from sore throat or cough, the medicines similar to them and also do not belong to sterile or prescription medicines;
proper production practice (Good Manufacturing Practice, GMP) - part of quality management which guarantees that medicines are constantly made and controlled according to the quality standards answering to their appointment and also according to requirements of the registration file, the file of the researched medicine for clinical testing or the specification for these products;
insignificant violation - violation of requirements of GMP which does not belong to critical or fundamental breaches (such classification is appropriated if discrepancy is estimated as such or if there is not enough information for discrepancy assessment as critical or essential);
the official document about compliance of conditions of production of medicines to requirements of GMP - the certificate of conformity of conditions of production of medicines to requirements of GMP issued by authorized body of the EU Member State, Great Britain or the country which has the agreement on mutual recognition with the EU or with Ukraine (data from the official electronic register - for FDA of the USA) or the license for production of medicines (if the authorized body of the EU Member State, Great Britain or the country having the agreement on mutual recognition with the EU or with Ukraine does not provide issue of the certificate of conformity of conditions of production of medicines to requirements of GMP);
confirmation of conformity of conditions of production of medicines to requirements of GMP - the procedure of confirmation Gosleksluzhboy of compliance of conditions of production of medicines to requirements of GMP by issue of the certificate of conformity of conditions of production of medicines to requirements of GMP or the conclusion concerning medicine production confirmation of conformity to requirements of GMP;
the representative Zayavitelya (the authorized person which is in Ukraine and acts on behalf of Zayavitelya) - the legal entity or physical person which is acting on the basis of the corresponding order (power of attorney) in which the Applicant grants the right to represent its interests when holding procedures of confirmation of conformity of conditions of production of medicines to requirements of GMP;
medicine prekvalifikation - the standardized procedure / program of the World Health Organization (WHO) which is carried out for the purpose of quality evaluation, safety and efficiency of medicine;
medicine of limited application (orphan medicine) - the medicine intended for diagnostics, prevention or treatment of rare disease, that is disease which threatens life or leads to disability (usually no more than 5 people from each 10000 inhabitants for date of filing of application about state registration);
products of "in bulk" - any medicine intended for production of ready medicine which took place all stages of engineering procedure, except stage of packing and/or final packaging and marking;
the certificate of conformity of conditions of production of medicines to requirements of GMP (further - the Certificate) - the document issued by Gosleksluzhboy by results of inspection which confirms compliance of conditions of production of medicines to the requirements of GMP existing in Ukraine;
difficult production process - process for which even insignificant variations in control parameters can lead to receipt of heterogeneous product or product which does not conform to requirements of the specification (for example, processes of homogenization or granulation for firm dosage forms with low dose, medicines of the prolonged or postponed action, sterile products);
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