News

The pharma markets in the Eurasian region are among the fastest growing and most commercially attractive markets for pharmaceutical and life sciences companies. The extremely high interest of pharmaceutical companies in these markets can be explained by the large region population (which is over 290 million), in proportion to the growing annual GDPandas well as the free market economy of EAEU. However, pharmaceutical companies seeking to reap the region’s benefits need to be entirely up to date with evolving legislation, which includes also the latest pharmacovigilance requirements, such as the requirement imposed by the Eurasian Economic Union Good Pharmacovigilance Practice (EAEU GVP) regarding the nomination of EAEU QPPV and LPPVs (Local Persons for PV) across EAEU, or even the requirements for nomination local QPPVs / LSRs across the rest of CIS countries outside of EAEU. In this article, we will introduce you to the legal requirements for the nomination of a local person for pharmacovigilance in the Eurasian region (EAEU and CIS). 

The requirement to appoint a Qualified Person for Pharmacovigilance in the EAEU (the EAEU QPPV)

Eurasian Economic Union consists of 5 member states (Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia). The legal pharmacovigilance system requirements of these Member States are described in the Eurasian Economic Union Good Pharmacovigilance Practice (EAEU GVP) guidelinesAccording to this document, the Marketing Authorization Holder must designate a Qualified Person responsible for Pharmacovigilance for the EAEU (the EAEU QPPVin one of the EAEU Member States 

The requirements for EAEU QPPV are similar to those of the EU QPPV within the EU GVP framework. Similarly, only one EAEU QPPV can be assigned to one pharmacovigilance system, as well as it is required that the EAEU QPPV should 

  • Reside and work in one of the EAEU member states.
  • Be available 24/7;
  • Have adequate theoretical and practical knowledge for the performance of pharmacovigilance activities;
  • Have skills for the management of pharmacovigilance systems as well as expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences as well as epidemiology and biostatistics;
The requirement to nominate pharmacovigilance contact persons on a national level in EAEU member states (the LPPVs)

In addition to the EAEU QPPV, according to the EAEU GVP guidelines, the competent authorities of the EAEU member states may lawfully request the appointment of pharmacovigilance contact persons on the national level (LPPV)The EAEU LPPVs represent MAHs PV operations on country-level across the Member States of EAEU and are accountable to the EAEU QPPV. One of the LPPVs may also act as the EAEU QPPV, and this is quite a typical scenario for many MAHs and PV systems in EAEU, especially smaller ones.  

It is worth mentioning that, although EAEU member states have transferred the LPPV requirements into their national laws, in practice, not all EAEU member states utilize the right to lawfully request LPPV appointment as provided in EAEU GVP. 

Therefore, with the right regulatory intelligence and understanding of expectations and practices of the health authorities, MAHs can develop efficient EAEU local PV system strategies, that could both save cost and assure all PV responsibilities are fulfilled. Contact us now to free advice on your EAEU local PV system strategy. 

The local PV person in Armenia must:  

  1. Have adequate theoretical and practical knowledge in the field of pharmacovigilance;   
  2. Hold an education minimum of bachelor degree in pharmacy, medicine, or related area; 
  3. Be available 24/7;  
  4. Reside and work in Armenia;

Legal References:

Pharmacovigilance Guideline for Marketing Authorisation Holders in Armenia Revision 1.0 November 2019; 

No. 87 of 3 November 2016 Rules of Good Pharmacovigilance Practise (GVP) of Eurasian Economic Union 

The local PV person in Belarus must:  

  1. Have the appropriate theoretical knowledge in the field of pharmacovigilance;  
  2. Have the skills to manage pharmacovigilance systems and carry out expertise or must have experience in areas such as medicine, pharmaceutical sciences, epidemiology, and biostatistics.  
  3. Be available 24/7;  
  4. Reside and work in Belarus;

Legal References:

No. 87 of 3 November 2016 Rules of Good Pharmacovigilance Practise (GVP) of Eurasian Economic Union; “Good Pharmacovigilance Practice” (approved and put into effect by the resolution of the Ministry of Health of the Republic of Belarus dated 04.06.2015 No. 80) 

The local PV person in Kazakhstan must:  

  1. Hold an education minimum of bachelor degree in pharmacy, medicine or related area; 
  2. Have the appropriate theoretical and practical knowledge in the field of pharmacovigilance;  
  3. Be properly trained to carry out PV activities;  
  4. Be available 24/7;  
  5. Reside and work in Kazakhstan;

Legal References:

No. 87 of 3 November 2016 Rules of Good Pharmacovigilance Practise (GVP) of Eurasian Economic Union; О внесении изменений в приказ Министра здравоохранения и социального развития Республики Казахстан от 27 мая 2015 года № 392 “Об утверждении надлежащих фармацевтических практик 

The local PV person in Kyrgyzstan must:  

  1. Hold an education minimum of bachelor degree in pharmacy, medicine or related area; 
  2. Have the appropriate theoretical knowledge in the field of pharmacovigilance;  
  3. Be properly trained to carry out PV activities;  
  4. Be available 24/7;  
  5. Reside and work in Kyrgyzstan; 

Legal references:  

No. 87 of 3 November 2016 Rules of Good Pharmacovigilance Practise (GVP) of Eurasian Economic Union; Article 11 of Law of the Kyrgyz Republic No. 91 “On Medicinal Products” dated 30 April 2003 

The local PV person in Russia must:  

  1. Hold an education minimum of bachelor degree in pharmacy, medicine or related area  
  2. Have the appropriate theoretical knowledge in the field of pharmacovigilance;  
  3. Be properly trained to carry out PV activities;  
  4. Be available 24/7;  
  5. Reside and work in Russia;  

Legal references:

No. 87 of 3 November 2016 Rules of Good Pharmacovigilance Practise (GVP) of Eurasian Economic Union; 

Requirements for the nomination of a local qualified person for pharmacovigilance (local QPPV) / Local Safety Responsible (LSR) in the rest of CIS countries (current and former members)

Unlike EAEU member states, where the MAHs are required to have a single EAEU QPPV region-wide (the EAEU QPPV) and may be required to nominate LPPVs across some or all EAEU member states, the remaining CIS countries (i.e. current and former countries of the Commonwealth of Independent States) that are not part of the EAEU each act as a separate legal system with its unique pharmacovigilance requirements 

If country belonging to the CIS region has its pharmacovigilance legislation in place, then the appointment of Local Safety Responsible, the local QPPV, is usually required. However, some CIS countries still do not have pharmacovigilance legislation in place and consequently have no national requirements for pharmacovigilance or local QPPV exist. 

Below we summarize which countries of CIS require the designation of a local QPPV and what requirements for the person’s qualifications apply. 

A local QPPV is Required in the country.

The local PV person (local QPPV) in Azerbaijan must:  

  1. Have the appropriate theoretical knowledge in the field of pharmacovigilance;
  2. Be available 24/7; 
  3. Reside and work in Azerbaijan; 
  4. Hold a higher education  in pharmacy, medicine, or related area; 

Legal References:

“On approval of the “Procedure for Pharmacological Control of Drugs”. (December 25, 2019 N503).

A local QPPV is Required in the country.

The local PV person (local QPPV) in Moldova must:  

  1. Live and work on the territory of the Republic of Moldova;  
  2. Have adequate theoretical and practical knowledge for the performance of PV activities;  
  3. Hold an education minimum of bachelor degree in pharmacy, medicine or related area;  
  4. Be available 24/7  
  5. Be properly trained to carry out PV activities; 

Legal References:

Order No. 358 from 12.05.2017 “On the approval of the “Implementing Regulation Pharmacovigilance Activities”. 

 If QPPV does not reside in Ukraine a single contact person responsible for pharmacovigilance (CPPV/local QPPV) shall be assigned.

The local person in Ukraine must:

1) Reside and work in Ukraine;

2) Hold a higher education of bachelor degree in pharmacy, medicine or related area (pharmacist, clinical pharmacist);

3) Be available 24/7;

4) Have the skills to manage pharmacovigilance systems and carry out expertise or have experience in areas such as medicine, pharmaceutical sciences, epidemiology, and biostatistics;

5) In cases where the CPPV/local QPPV in Ukraine does not have higher medical education following Article 24 of Directive 2005/36/EC [10] and the provisions of Procedure [2], the Applicant (Marketing Authorization Holder) must provide access to the local QPPV/CPPV in Ukraine to a specialist with higher medical education (i.e. following Article 24 of Directive 2005/36/EC [10] and the provisions of Procedure [2] N) to receive assistance from him, and this must be properly documented (Article 10 (1) IP 520/2012 [6] and the provisions of Procedure [2]).;

6) Be properly trained to carry out PV activities.

Legal References:

42-8.7:2018 Medicinal Products. Guideline on good pharmacovigilance practices. Order of Ministry of Health of Ukraine №898; Article 24 of Directive 2005/36/EC [10] and the provisions of Procedure [2]; 26.09.2016 Order On the introduction of changes to some Orders of the Ministry of Health of Ukraine; 

A local QPPV is Required in a country.

The local PV person in Uzbekistan must:  

  1. Have the appropriate theoretical knowledge in the field of pharmacovigilance;  
  2. Hold an education minimum of bachelor degree in pharmacy, medicine or related area; 
  3. Be properly trained to carry out PV activities;  
  4. Be available 24/7;  
  5. Reside and work in Uzbekistan;  

Legal references:  

Law of the Republic of Uzbekistan “On medicinal products and pharmaceutical activity”

It is not required to designate a local QPPV, however, the legislation of Turkmenistan regarding pharmacovigilance is in the process of development – contact us for any updates. 

A local QPPV is not required in the country.

A local QPPV is not required in the country.

A local QPPV is not required in the country.

At Insuvia, we specialize in country-level PV operations.

Click here to view all our local PV services  or  contact us  to discuss the regional and local PV requirements and potential ways of how these requirements could be fulfilled effectively with our help.