Wholesalers
Use of the medicine authenticity control system
Checking security features
Every company operating in Estonia with a pharmaceutical wholesale license that physically handles pharmaceutical packaging must ensure appropriate operations, including, if necessary, developments, to meet the requirements of the European Commission's Falsified Medicines Directive (2011/62/EU) and applicable national legislation. It is the responsibility of every wholesaler to ensure that the necessary processes for proper verification of the authenticity of medicines are integrated in their establishment.
Assessing the need for drug testing
We recommend first analyzing the supply chain to assess which manufacturers' medicinal products must definitely be checked for authenticity and which ones do not need to be checked for authenticity if the wholesaler has been designated as a " Designated Wholesaler " by the respective manufacturer in accordance with Article 20(b) of the Delegated Regulation. This analysis helps to ensure that all required medicinal products undergo authenticity checks and at the same time optimize resources for those medicinal product packages that reach the wholesaler from the marketing authorization holder/manufacturer for whom the company is designated as a wholesaler in the REKS database (EU-HUB). Please note that the designation of the manufacturer/marketing authorization holder as a designated wholesaler is an option and decision, but not an obligation . Wholesalers are obliged , pursuant to Article 23 of the Delegated Regulation, to check the authenticity of the safety features of medicinal products for a certain end user and to remove the unique identifier from use. This list varies in each Member State and in Estonia it is regulated by Section 44(4) of the Medicinal Products Act .
The authenticity of the medicine packaging can be checked by reading the 2D security code on the packaging with a scanner or by manually entering the data on the packaging.
If the end user is unable to verify the authenticity or deactivate the medicinal products due to a technical problem , then in accordance with the Delegated Regulation (excerpt attached below), the details of the dispensing package must be recorded and, if possible, a picture taken of it so that the packaging can be disposed of later .
Contract with REKS
The wholesaler is required to sign a contract with REKS. The contract is concluded with the pharmacy as a legal entity, not with each pharmacy location. To receive a draft contract, please send an e-mail to REKS: info(at)reks.ee
The following must be submitted with the contract:
End-user information system and information system developer data . In the event of technical problems or errors, REKS can contact the developer directly.
Contact details of the recipient of software updates – we recommend that you provide the details of either the pharmacy's IT contact person and/or the developer's contact person here.
Contact details of the recipient of general system notifications – we recommend providing the contact details of the person who, if necessary, could share the information directly with the pharmacy. For example, if the entire system is disrupted and the pharmacy has to dispense medicines without checking their authenticity (in such a case, the wholesaler must retain the code information in order to check and deactivate them later when the system is restored).
Interfacing the wholesaler's information system with the REKS database
The wholesaler can interface their own information system with the REKS database system, in which the necessary developments have been made, or use the free REKS web solution.
Steps required to interface with wholesaler software:
First, it is necessary to order the development of the pharmacy information system from your developer.
The information system developer must sign a confidentiality agreement with REKS to gain access to the technical documentation. Once the confidentiality agreement has been signed, the developer can register on the developer portal .
REKS then accepts the developer's registration and access to the technical documentation is provided through the portal. All technical documents are made available through the portal. This ensures that only authorized people have access to the documents and are immediately informed of any documentation updates.
Developers are required to follow technical specifications and requirements when interfacing with the system and to independently confirm the quality of the developments after the interface is implemented.
Wholesalers are advised to request a user manual or training from their information system developer regarding the changes introduced.
After completing the technical interface, the developer must undergo BaseLine testing.
To create a user account, the end user must first enter into an end user agreement with REKS and submit a request to create an administrator account. The request must be signed by a person with the company's signature authority .
REKS creates an administrator account for the wholesaler. The administrator can manage all users in his system, including adding users. REKS cannot do this, including, for example, unlocking the password, etc.).
NB! The end user is responsible for interfacing the end user information system and performing the necessary developments!
Obligations in the event that it is not possible to verify the authenticity of a unique identifier and remove it from use.
Notwithstanding Article 25(1), where persons authorised or entitled to supply medicinal products to the public are unable , due to a technical problem, to verify the authenticity of the unique identifier of a medicinal product bearing a unique identifier and to remove it from use at the time of supply to the public, those persons shall record the unique identifier concerned and verify its authenticity and remove it from use as soon as the technical problem has been resolved .
To create a user account, the pharmacy must first enter into an end-user agreement with REKS and submit a request to create an administrator account. The request must be signed by a person with the company's signature authority .
REKS creates an administrator account for the pharmacy. The administrator can manage all users in their system, including adding users. REKS cannot do this, including, for example, unlocking the password, etc.). You can read more about this in the Instructions sub-section.
In the REKS online solution, you cannot use a scanner to check codes. The entire check can be performed manually (for this, it is necessary to manually enter the codes visible on the medicine packaging into the online form).
Article 29
(extract from the Delegated Regulation)
Obligations in the event that it is not possible to verify the authenticity of a unique identifier and remove it from use.
Notwithstanding Article 25(1), where persons authorised or entitled to supply medicinal products to the public are unable, due to a technical problem, to verify the authenticity of the unique identifier of a medicinal product bearing a unique identifier and to remove it from use at the time of supply to the public, those persons shall record the unique identifier concerned and verify its authenticity and remove it from use as soon as the technical problem has been resolved.