ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of December 14, 2009 No. 944

About approval of the Procedure for carrying out preclinical studying of medicines and examinations of materials of preclinical studying of medicines

According to article 6 of the Law of Ukraine "About medicines" and for the purpose of enhancement of carrying out preclinical studying of medicines which move on state registration, conducting examination of materials of preclinical studying of medicines I ORDER:

1. Approve the Procedure for carrying out preclinical studying of medicines and examination of materials of preclinical studying of medicines which is applied.

2. Declare invalid the order MZ of 01.11.2001 N 441, "About Approval of the Procedure for Carrying Out Preclinical Studying of Medicines, the Procedure for Determination of Organizations Which Carry Out Preclinical Studying of Medicines" registered in the Ministry of Justice of Ukraine 20.11.2001 for N 972/6163.

3. To the director of the department of regulatory policy in the field of drug circulation and products in MZ health care system Konstantinov Yu. B. provide submission of this order in accordance with the established procedure on state registration in the Ministry of Justice of Ukraine.

4. To impose control over the implementation of this order on the deputy minister Mitnik Z. M.

5. The order becomes effective from the date of its official publication.

The Order of the Ministry of Health of Ukraine of December 14, 2009 is approved No. 944

Procedure for carrying out preclinical studying of medicines and examination of materials of preclinical studying of medicines

I. General provisions

1. The procedure for carrying out preclinical studying of medicines and examination of materials of preclinical studying of medicines (further - the Procedure) is developed according to article 6 of the Law of Ukraine "About medicines", the Law of Ukraine "About protection of animals against cruel manner", installations "Medicines. Proper laboratory practice", Ukraine approved by the order of the Ministry of Health of 16.02.2009 N 95 "About document approval concerning quality assurance of medicines" (Proper laboratory practice is farther), and taking into account regulations which are applied in the international practice.

2. The procedure determines the main requirements to carrying out preclinical studying of medicines and examination of materials of preclinical studying of medicines and extends to active ingredients, excipients, finished pharmaceutical products (except for medical immunobiological medicines), including herbal remedies, medicinal cosmetics, disinfection, diagnostic and radioactive medicines.

3. Preclinical studying of medicines is carried out by research organizations irrespective of pattern of ownership and departmental subordination which are capable to provide the appropriate scientific and methodical level of preclinical studying of safety and efficiency of medicines and proper observance, according to the current legislation, the principles of humane treatment of experimental animals in case of their use.

4. In this Procedure terms are used in such value:

audit of preclinical studying - comparison of basic data of preclinical research of medicine and the relevant data provided in the report on preclinical research of medicine, for the purpose of determination, completeness and the validity of statement of basic data of preclinical research, compliance of carrying out research to the protocol (plan) of preclinical research and standard operational procedures, for obtaining which is not displayed in the report on preclinical research of medicine of the additional information, for assessment of adequacy of method of receipt of basic data, and also compliance of the conducted preclinical researches to requirements of Proper laboratory practice;

multicenter preclinical research - studying of medicine which is performed more than one research organization according to the single protocol (plan) of preclinical research;

basic data - all primary records and documents of research organization or the copy certified by the head of research which are result of observations and actions during the research. Basic data of preclinical studying of medicine can also include, for example, photos, microfilms or copies of microfiches, information for reading on the computer, the dictated observations, data recording from the automated devices or any other means of preserving information, capable it is safe to store information;

variations from the protocol (plan) of research - departure unexpected in advance from the protocol (plan) of research later began researches;

secondary pharmakodinamika - pharmakodinamika subsection which studies the mechanism of effect of medicines and set of its effects which do not concern particular purpose of pharmacotherapy;

the chief researcher - person who when carrying out multicenter research of medicine acts on behalf of the head of research and is responsible for the phase of preclinical research of medicine delegated to it;

start date of experiment - the date of receipt of the first data of preclinical research of medicine;

end date of experiment - the date of receipt of the latest data of preclinical research of medicine;

start date of research - signature date the head of research of medicine of the protocol (plan) of preclinical research;

date of completion of research - signature date the head of research of the report on preclinical research of medicine;

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