New good pharmacy practice for medicines intended for human use

As opposed to the earlier regulation, GPP places special emphasis on maintaining a QA system. GPP introduces a list of measures related to how pharmacy products should be sold in retail chains.

GPP defines a list of QA documents (over 30 mandatory documents). It also lays down a regulation that the manager of a retail pharmacy store is to appoint the persons responsible for the maintenance and storage of such documents. 

2. The scope of responsibilities of the manager of a retail pharmacy store is defined

Under the new requirements, the manager of a retail pharmacy store has a broad range of powers and responsibilities. Specifically, the manager ensures that production losses are reduced, measures are undertaken to encourage and motivate employees, the company’s operations are streamlined, and the turnover of goods is increased. He/she is also responsible for advancing the expertise and qualifications of the pharmacists and managing the pharmacy’s procurement system.

Further, monitoring the procedure for selecting and assessing suppliers based on specified criteria also falls within the manager's authority. His/her powers also include overseeing compliance with special requirements when goods are accepted and operations are assessed.

3. Requirements for personnel are established

GPP summarises the list of requirements for employees and their qualifications. A special adaptation programme must be introduced for new employees. Also, the qualifications of existing employees should also be checked on a regular basis. The new GPP determines the main functions of pharmacists.

According to GPP, the manager of a retail pharmacy store ensures that its employees take training in such matters as: the rules for selling medicines intended for human use, and for selling narcotic drugs and psychotropic substances; the procedure for keeping prescriptions; and meeting the requirements for a minimum product range.

4. Requirements for infrastructure are introduced

GPP sets clear requirements for premises. 

Specifically, GPP determines the way premises should be laid out in a building. It specifies that premises should be functionally joined together while being isolated from other premises and that no unauthorised access by third parties is permitted. GPP sets certain requirements for signs at a retail pharmacy store, for the floor area and lighting, and for the display of medicines in the windows and on the shelves. 

PG comments: Since GPP unifies and systematises the basic important requirements for the retailing of medicines intended for human use, GPP's entry into effect may allow for a pharmacy business to be raised to a new quality level based on the principles of transparent interaction with consumers and statutory compliance.
In our opinion, the adoption of GPP in Russia will streamline the operations of pharmacy companies and regulate the management of QA systems in a precise manner. This will help to raise the level of the services provided. At the same time, the regulatory authority must be ready to give timely and on-point answers to requests seeking explanations of certain provisions of GPP. It needs to apply a unified risk-oriented approach, as well as to ensure uniform implementation of GPP. Otherwise, the unclear requirements and varying understandings of GPP on the ground may lead to a significant increase in the administrative burden on the retail sector. 

What to think about

In view of the new provisions, we recommend that retailers trading in medicines familiarise themselves with GPP. Then, if anything is not clear for them, they would be well advised to send their requests to a state authority in a timely fashion, either independently, via non-commercial sector-based associations, or with the assistance of our specialists.

Once GPP comes into force, documents need to be drafted and new measures need to be introduced in accordance with the new requirements. 

Help from your advisers

Pepeliaev Group’s experts have extensive experience of advising and representing clients with regard to complying with Russian legislation on pharmacy business. Our lawyers are ready to provide comprehensive assistance and legal support in any matters related to how GPP is to be applied.