The inspection is the external test. The inspection on compliance with pharmacovigilance requirements by the market authorization holders is carried out by the regulatory bodies of the EAEU state-members. The pharmacovigilance inspections should be held by the inspectors, appointed by the national regulatory bodies, authorized to hold the examination of the indoor space, to get acquainted with the registration holder’s or other organizations’, attracted by the registration holder for pharmacovigilance obligations fulfillment, materials, documents and master-file of the pharmacovigilance system. The market authorization holders have to present the pharmacovigilance system master file which will be used for the informing about the inspections, at the first request of the regulatory bodies.[1]

     The goals of pharmacovigilance inspections comprise:

  1. a) the confirmation that the market authorization holder has the staff, systems and also indoor space, means and equipment necessary for the fulfilling his obligations on pharmacovigilance;
  2. b) identification, estimation, registration and informing of the inspected side about the non-compliances, which may jeopardize the public health;
  3. c) using the inspection results as the base for the mandatory actions for the market authorization holder if necessary[1].

     The regulatory body has the right to conduct pharmacovigilance inspections prior to the registration of medicinal products to verify that the current pharmacovigilance system of the registration certificate holder meets the requirements of legislation and good pharmacovigilance practices. The regulatory authorities of the state-members of the EAEU interact to exchange information regarding inspections that are planned and the results of inspections that have already been carried out[1].

     The pharmacovigilance department must be constantly ready for inspection by regulatory authorities. But you need to understand that the inspectors will also come to the marketing departments to check whether marketing sales are conducted correctly from the pharmacovigilance  point of view. The inspectors will also check the sales department, as these employees actively communicate with doctors and can get safety information from them.[2]

     Inspections can be routine or unannounced inspection.

Routine pharmacovigilance inspections are performed in accordance with a pre-drawn up inspection program. In order to optimize the planning of measures to control the functioning of the pharmacovigilance system, it is recommended to use an approach based on the assessment of potential risks of non-compliance with the relevant obligations. Routine inspections are system inspections, but you can choose one or more specific medicines as examples to check the functioning of the pharmacovigilance system and obtain practical evidence of its effective functioning and compliance. The standard inspection program can, for example, include the assessment of the state of the system for specific problems identified by experts.

Unannounced inspections of the pharmacovigilance system are carried out if the initiating factor (a system problem) is identified, and the inspection is considered as the best way to study and evaluate the identified problem. The unannounced inspections are aimed at evaluating specific pharmacovigilance processes or include the study of the identified problem (issues) and their impact on a specific medical drug. In certain cases, according to the identified initiating problem, inspections can be performed with a complete assessment of the pharmacovigilance system. Unannounced inspections are performed if one or more of the following initiating factors are detected:

1) in relation to the benefit-risk analysis of the medical drug:

  1. a) a change in the benefit-risk ratio if further evaluation of the system through inspection is deemed necessary;
  2. b) delay in implementation, or improper implementation of the procedure for identifying risk or informing about changes in the benefit-risk ratio, or failure to comply with this procedure;
  3. c) providing information on pharmacovigilance issues to the mass media without prior or simultaneous notification of the national regulatory authorities;
  4. d) non-compliance with legal requirements or obligations to ensure the safety of the medicinal product identified during monitoring of pharmacovigilance activities by national regulatory authorities;
  5. e) suspension or withdrawal of a medicinal product without prior notification to regulatory authorities;

2) reporting obligations (urgent and periodic):

  1. a) delays or omissions in providing safety information in accordance with the applicable statutory requirements;
  2. b) low quality or incomplete information provided;
  3. c) inconsistencies between the information provided and other sources of information;

3) requests from regulatory authorities:

  1. a) refusal to provide the requested information or data within the time limits established by the regulatory authorities;
  2. b) poor quality or poor presentation of data in response to requests from regulatory authorities for information;

4) fulfillment of obligations:

  1. a) concerns about the status or performance of obligations under the risk management plan;
  2. b) delays or non-fulfillment of specific obligations related to product safety monitoring identified during the issuance of the state registration certificate;
  3. c) poor quality of reports requested as specific obligations;

5) inspections:

  1. a) delays in implementation or improper implementation of corrective and preventive actions;
  2. b) information about non-compliance with legal requirements or obligations to ensure the safety of the drug obtained during other types of inspections (Good clinical practice (GCP), Good manufacturing practice (GMP), Good laboratory practice (GLP) and Good distribution practice (GDP);
  3. c) verification of information received from other regulatory authorities that may reveal inconsistencies in the system;

6) other:

  1. a) problems identified when reviewing the master file of the pharmacovigilance system;
  2. b) other sources of information or complaints[1].

If the inspection reveals that the market authorization holder does not comply with its pharmacovigilance obligations, the EAEU member – state has to inform other EAEU states- members about the identified violation. If necessary, the EAEU member state should take the appropriate measures to ensure that effective, proportionate and dissuasive sanctions are applied to the holder of the registration certificate. Information about the results and inspection conduction within the framework of pharmacovigilance, as well as subsequent monitoring and evaluation of consequences, is posted by the EAEU member states on the websites of the relevant regulatory authorities[1].

According to Russian law, especially Federal law No. 61-FL “About the drug circulation” (hereinafter referred to as FL-61), the code of administrative offences and even the criminal Code of the Russian Federation, regulatory authorities have the right to impose fines of up to 300 thousand rubles on companies and their employees and to suspend or cancel state registration, up to imprisonment for guilty managers and employees of companies for up to 2 years[2].

Literary sources:

1. Правила надлежащей практики фармаконадзора [Электронный ресурс]: http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/konsultComitet/Documents/%D0%9D%D0%B0%D0%B4%D0%BB%D0%B5%D0%B6%D0%B0%D1%89%D0%B0%D1%8F%20%D0%BF%D1%80%D0%B0%D0%BA%D1%82%D0%B8%D0%BA%D0%B0%20%D0%BF%D0%BE%20%D1%84%D0%B0%D1%80%D0%BC%D0%B0%D0%BA%D0%BE%D0%BD%D0%B0%D0%B4%D0%B7%D0%BE%D1%80%D1%83%20%D1%80%D0%B5%D0%B4%2009%2009%202014.pdf
2. Ссылка на источник: http://mosapteki.ru/material/bud-gotov-k-revolyucionnym-izmeneniyam-v-farmakonadzore-6131