ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of July 22, 2015 No. 452

About modification 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", to 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, to Item 5 of the Procedure of the state quality control of the medicines imported into Ukraine, the Cabinet of Ministers of Ukraine approved by the resolution 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:

1. Make changes to the Procedure for carrying out confirmation of conformity of conditions of production of medicines to requirements of proper production practice approved by the order of the Ministry of Health of Ukraine of December 27, 2012 No. 1130, registered on January 21, 2013 for No. 133/22665, having been reworded as follows it which is applied the Ministry of Justice of Ukraine.

2. To pharmaceutical products (T. Lyaskovsky) in accordance with the established procedure to provide to management of pharmaceutical activities and quality submission of this order on state registration in the Ministry of Justice of Ukraine.

3. I reserve control of execution of this order.

4. This order becomes effective from the date of its official publication.

Approved by the Order of the Ministry of Health of Ukraine of December 27, 2012, No. 1130

(in edition of the Order of the Ministry of Health of Ukraine of July 22, 2015 No. 452)

Procedure for carrying out confirmation of conformity of conditions of production of medicines to requirements of proper production practice

I. General provisions

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 6, 2001 concerning the Code of Community concerning the medicines intended for application by the person, the Directive of the Commission 2003/94/EU of November 08, 2003 which establishes the principles and rules of proper production practice concerning the medicines intended for application by the person and the 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 the document of the international system of cooperation of pharmaceutical inspections (PIC/S) РІ 002-3 Requirements to the quality system of pharmaceutical inspectorates.

2. In this Procedure terms are used in the following values:

active pharmaceutical ingredient (medicinal substance, active ingredient, substance) (further - AFI or active ingredient) - any substance or mix of substances, held for use in production of medicine and in case of this use becomes its active ingredient. Such substances have pharmacological or other direct impact 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 on quality control and safety of medicines which underwent industry certification Gosleksluzhboy of Ukraine;

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 on 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 about confirmation of conformity of conditions of production of medicine to requirements of proper production practice (further - the conclusion) the document issued by Public service of Ukraine on medicines (further - Gosleksluzhba of Ukraine) which demonstrates 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 GMP issued by authorized body of the member country PIC/S 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 represents to Gosleksluzhbu of Ukraine personally or through the authorized person (representative) who 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 about confirmation of conformity of conditions of production of medicine to requirements of proper production practice (further - the statement) and responsible for reliability of provided information and documents;

sample (test) from series - the part from series which is selected thus and in such quantity that is representative for all series;

the inspector - the official Gosleksluzhby of Ukraine 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 company 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 with the contract (agreement));

PIC/S member country - the country having authorized body in the field of quality control of medicines which is member of the international System of cooperation of pharmaceutical inspections (Pharmaceutical Inspection Cooperation Scheme, PIC/S);

critical violation - violation of requirements of proper production practice which leads to production of medicine, the life-threatening person, or high risk of production of such medicine;

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 for their production difficult production processes are used;

medicine of high risk - medicine which can represent risk for health of the person even in case of small quantities as a result of 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 containing medicines; remedies from solar burns; lollipops from sore throat or cough, the medicines similar to them, and also such which 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 which correspond 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 country of the member of PIC/S or the license for production of medicines (if the authorized body of the member country PIC/S does not provide issue of the Certificate of conformity of conditions of production of medicines to requirements of GMP);

primary examination - check of the completeness of the submitted documents and compliance of such documents to the legislation, including requirements of this Procedure which is carried out by workers of Gosleksluzhby of Ukraine;

confirmation of conformity of conditions of production of medicines to requirements of GMP - the procedure of confirmation Gosleksluzhboy of Ukraine 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 about medicine production confirmation of conformity to requirements of GMP;

the applicant's representative (the authorized person which is in Ukraine and acts on behalf of the applicant) - 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 in Ukraine when holding procedures of confirmation of conformity of conditions of production of medicines to requirements of GMP;

medicine prekvalifikation - the standardized procedure / program of WHO which is carried out for the purpose of quality evaluation, safety and efficiency of medicine;

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