Qualified persons - transition to new requirements and certification regulations Pyatigorskaya Nataliya Valeryevna Sechenov University Expert group for certification of Qualified persons of pharmaceutical manufacturers

REGULATORY REQUIREMENTS Eurasian Economic Commission​​ (EEC) Council Decision No. 73 “On the certification procedure of Qualified persons of pharmaceutical manufacturers” dated 03.11.2016 EEC Council Decision No. 74 “On approval of the Procedure for the formation and maintenance of the register of QP of pharmaceutical manufacturers of the EAEU” dated 03.11.2016 EEC Council Decision No. 77 “On the Approval of the Rules of Good Manufacturing Practice of the EAEU” dated 03.11.2016 EEC Council Decision No. 78 “On the Rules for the Registration and Expertise of human medicinal products” dated 03.11.2016 Federal Law No. 61-FZ “On drug circulation” (as amended by No. 449-FZ) dated 12.04.2010

Article 45. Manufacture of medicines Federal Law No. 61-FZ “On drug circulation” Article 45. Manufacture of medicines 7. The Qualified person of the pharmaceutical manufacturer is his employee, certified by an authorized federal agency and having at least five years work experience in the field of production and (or) quality control of medicines, higher education in one of the specialties and (or) respectively one of the academic majors: biology, biotechnology, veterinary medicine, clinical medicine, radiological, chemical and biological protection, pharmacy, fundamental medicine , chemical technology, chemistry. DRAFT 25/10/2018 «7.1. The Qualified person of the pharmaceutical manufacturer is his employee, certified by an authorized federal agency in accordance with the law of the Eurasian Economic Union».

EEC Council Decision No EEC Council Decision No. 73 “On the certification procedure of Qualified persons of pharmaceutical manufacturers” The person to be certified must have at least three years of work experience in the field of production, or quality assurance, or quality control of medicines and finished higher education in one of the following areas: chemical, chemical-technological, chemical-pharmaceutical, biological, biotechnological, microbiological, pharmaceutical medical or veterinary. Persons with finished higher education in the field of physical and technical sciences are also allowed to be attested for the right to perform functions of an Qualified person at enterprises engaged in the production of medical gases. In the production of radiopharmaceuticals persons with finished higher education in the field of nuclear physics and radiophysics are also allowed to be attested as Qualified person (Nuclear Energy and Technology, Radiophysics)

Requirements for training courses (disciplines, modules), came into force on January 1, 2019 The person to be certified (except for QP for medical gases and radiopharmaceuticals), upon receiving higher or additional education, must undergo training in the following courses (disciplines, modules): applied (medical and biological) physics; general and inorganic chemistry; organic chemistry; analytical chemistry; pharmaceutical chemistry (including drug analysis); biological chemistry; physiology; microbiology; pharmacology; pharmaceutical technology; toxicology; pharmacognosy.

Chemical technology - specialty life cycle Letter of the Ministry of Education and Science dated 24.06.2014 N AK-1666/05 "On the establishment of correspondence ... .. specified in previous lists of professions, specialties and training areas" 1. Recycling technology of industrial secondary materials. 2. Energy and resource saving processes in chemical technology, petrochemistry and biotechnology 3. Chemical technology 1. Technology of inorganic substances and chemical fertilizers. 2. Chemical technology of inorganic substances The field of professional activity of graduates who have mastered the program includes: development of scientific foundations, creation and implementation of energy and resource-saving, environmentally friendly technologies in the production of basic inorganic substances, products of basic and fine organic synthesis, polymeric materials, products of oil, gas and solid fuel processing, microbiological synthesis, drugs and food products, development of handling methods for industrial and domestic wastes and secondary raw materials.

Proposals for optimization of the certification procedure of Qualified persons Reconsider the Order of the Ministry of Health of Russia No. 811n “On approval of the Certification Procedure for an authorized person of a manufacturer of medicines for medical use” dated 01.11.2013 as a matter of law of the Eurasian Economic Union regarding: determination of type(s) of activity for the production of medicines in accordance with the requirements of EAEU law, GMP rules, and the need and feasibility of additional certification of QP when changing type(s) of this activity; establishing an inclusive list of specialties and areas of training that will be unambiguously recognized by the Coordinating Council of Certification Commission establishing the procedure for informing the Certification Commission in case of change of the place of work and position of the certified Qualified person; harmonizing the requirements for the information provided by the applicant for certification with the requirements contained in the EEC Council Decision No. 74 “On approval of the Procedure for the formation and maintenance of the register of QP of pharmaceutical manufacturers of the EAEU”;

Proposals for optimization of the certification procedure of Qualified persons Harmonize The Terms and definitions in GMP Rules regarding “authorized person” (Appendix No. 2 “Requirements for the production of biological (including immunobiological) active pharmaceutical substances and drug products”) and “Qualified person” in Appendix No. 14 “Requirements for the production of drugs received from donated blood or plasma ”. Draw attention of the EEC Commission to the fact that existing web-site http://www.eurasiancommission.org/ of EEC Unified Register of QP does not meet the requirements of the EEC Council Decision No. 74. Develop a verification procedure of higher or additional education received by a certified Qualified person (in accordance with EEC Council DecisionNo. 73) for subsequent inclusion in the Unified Register of Qualified Persons of the Eurasian Economic Union. Establish the necessary volume of courses (disciplines, modules) required by the EAEU legislation, for evaluating applicants and possible mutual recognition of training / education and certification. Prepare qualification requirements for QP and initiate introduction of the position “Qualified person” in job evaluation catalogs.

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