Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Normative Documentation in CIS region. Challenges for an EU Marketing Authorization Holder ***

Kateryna Popova (Abschlußjahr: 2020)

Summary
Language: English
The master thesis researches the legislative and historical background of and summarizes the requirements for the Normative Documentation (ND) within the countries of Commonwealth of Independent States (CIS) region. It also includes the description of the differences thereof between the countries concerned.
The ND is a specific document defining the quality of the medicinal product and it is required in some of the countries in the CIS region for gaining the Marketing Authorization (MA) as well as during the life cycle of a medicinal product. Although most of the requirements to the documentation necessary for the MA of the medicines in the CIS countries are comparable with the requirements in the EU, the ND still stays a national specific document and it is evaluated during the MA expertise together with the dossier and is approved by the National Competent Authority (NCA).
An EU QP of a pharmaceutical company is responsible for overall product’s quality and confirms the compliance of the product to the applicable legal requirements in the country of origin as well as its compliance to the product’s marketing authorization. Therefore the compliance of the product’s batch with the approved ND must be ensured by the QP of an EU pharmaceutical company for releasing the product for the countries where this document is a part of the MA.
The structure of the ND as well as the corresponding links between a ND and the CTD dossier modules in the EU are analysed. The structure of the document as well as the information included in it is quite similar in the different countries of the region. However, several specifics exist, some of which are also described in the thesis.  
The position of a ND in the registration dossier is provided as well as the specifics and challenges of the cooperation with the local partner during the compiling of the document. The stepwise approach is illustrated showing the dossier preparation stage at which a ND is compiled as well as the level of EU Marketing Authorization Holder (MAH) involvement depending on the company’s structure and agreed extent of the responsibility of a local partner.
A major role in preventing incompliances related to the ND is given to the local partner and his/her bilateral function of communicator between the NCA – ensuring compliance with current local legislation, and the MAH – ensuring compliance with the company’s dossier and processes.
The latest legislative developments in the region related to the activation of the Eurasian Economic Union (EAEU) requirements for medicinal product MAs and to the ND as a part of the EAEU MA dossier are indicated as well. The ND stays an important part of the dossier in the EAEU member states and will also have to be implemented in Armenia, where this document has not been required before.
The latest part of the thesis provides the details of the influence of the ND on the quality supply chain documentation accompanying the batches of the product after the release on the market and the impact on the customs clearance of goods in the countries of the CIS region.
The summarized list of the potential challenges related to the ND, its compiling and maintenance is added to highlight the important points for consideration as part of planning of the MA procedures and regulatory life cycle in the CIS region.  
Pages: 69
Annexes: 11, Pages: 44