Wholesalers

Wholesalers

               Updated 04.02.2020

WHOLESALER RESPONSIBILITIES FOR SECURITY FEATURES

Any company licensed for the wholesale distribution of medicinal products in Estonia and physically handling the packaging of medicinal products must carry out the development and necessary actions in order to comply with the requirements of the European Commission Falsified Medicines Directive (2011/62/EU) and applicable national legislation. It is the responsibility of each wholesaler to ensure that the necessary processes to properly verify the authenticity of the medicinal products are integrated within their establishment.

ASSESSMENT OF THE NEED OF MEDICINE VERIFICATION

We recommend that you first analyse the supply chain to determine which manufacturers’ medicines definitely need to be verified and which ones are not required, as the wholesaler is designated by the respective manufacturer as “Designated Wholesaler” under Article 20 (b) of the Delegated Regulation. This analysis helps to ensure that all required medicines pass the verification check, while optimising resources for those pharmaceutical packages that reach the wholesaler by the Marketing Authorisation Holder / Manufacturer designated as a wholesaler in the REKS database (EU-HUB). Please note that designation as a designated wholesaler is an option and a decision, but not an obligation of the manufacturer / marketing authorisation holder. Wholesalers are required by Article 23 of the Delegated Regulation to verify the security features of medicinal products and to remove a unique identifier for some end users. The list varies from one-member state to another and is regulated in Estonia by Section 44 (4) of the Medicinal Product Act.

The code is verified from the Estonian National Medicines Verification System, which is managed by REKS. The code can be verified by a scanner and by manually entering the data on the package.

END USER CONTRACT WITH REKS

It is necessary to sign a contract with REKS. The contract is signed with legal entities, not with each wholesaler location.
For the draft contract, please send an email to (info@reks.ee)
The contract shall be accompanied by:

  1. End user software system details and the software supplier contact int case of a major problems or failures REKS could contact them directly.
  2. Software Update Recipient contact details – we recommend that you provide here either an IT contact person or, if you prefer, a direct contact with the developer.
  3. General System Notification Recipient contact details – we recommend that you provide contact details of a person who can share directly the information with the wholesaler if needed, e.g. in a case of system disruption and the wholesaler needs to dispense the medicines without the verification (in this case, the wholesaler must retain packaging code information to perform the verification and deactivate the package once the system is running again).

In a case when the end user terminates its activity in Estonia and no longer has a valid license, it is also obliged to terminate the contract with REKS. In addition, the end user is responsible for ensuring that all user accounts created are “locked”, this is that unauthorised persons do not have access to EtMVS.

To end the contract, the wholesaler shall send an email request to determine the contract with REKS. The email sender, or at least in the copy of the email, should be the person who signed the contract, that is, the end-user legal representative with the right to sign.

INTERFACING THE INFORMATION SYSTEM WITH REKS DATABASE SYSTEM

The wholesaler can interface their own information system that has been developed with REKS database system or use a free web solution created by REKS.

Steps required to interface the wholesaler software:

  • It is necessary for the wholesaler to order the development of its software supplier to interface with the database
  • In order to access the technical documentation, the software supplier has to sign a confidentiality agreement with REKS. Once it has been signed, the software supplier can register on the developer portal (https://www.sws-nmvs.eu).
  • Thereafter, REKS will accept the developer’s registration and access to the documents will be provided through the portal. All technical documents are made available through the portal. This ensures that only authorised people have access to the documentation, and that all developers are immediately up to date with documentation updates.
  • Developers are required to adhere to the technical specifications and requirements when interfacing with the system, and to confirm the quality of their development after the interface is implemented.
  • It is advisable for the wholesaler to ask the developer of their information system for user manuals or training regarding the changes made.
  • After the technical interface is completed, the developer must pass BaseLine test and REKS will issue a certificate to the developer.
  • To create a user account, the wholesaler must first sign a contract with REKS and then apply for an administration account. The application must be signed by a person authorised to sign it.
  • REKS creates an administration account, on the basis of which an administrator account certificate is issued for the use of REKS database. It is the responsibility of the end user to integrate the certificate into their own information system and to ensure the creation of other user accounts for the authority.

NB! Interfacing the end-user information system and the necessary developments is the end-user’s responsibility!

REKS FREE WEB SOLUTION
  • To create a user account, the wholesaler must first sign a contract with REKS and then apply for an administration account. The application must be signed by a person authorised to sign it.
  • REKS creates an administrator account, on the basis of which an administrator account certificate is issued for the use of REKS database. The end user must download the certificate, log in to the information system (the necessary codes and web address will be forwarded by automatic email).
  • The user must create a role for his/her authority to fulfil the necessary duties and create a new user. A person with administration rights is more like an account manager, and substantive rights need to be given a separate role such as “master user” or “user”.

Scanners cannot be used to verify codes in REKS web solution. All testing can be done manually (this requires the codes to be visible on the package).

PURCHASE OF 2D CODE SCANNERS FOR VERIFICATION
It is important to communicate with the software supplier regarding the scanner models, as scanners must be able to automatically perform verification and must therefore be compatible with the wholesaler information system.

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