Pharmacies
Use of the medicine authenticity control system
Checking security features
Pharmacies and hospital pharmacies that dispense medicines to the public must verify the authenticity of the code on the medicine packaging before dispensing the medicine to patients and then deactivate the code, i.e. remove it from use. This must be done on each serialized medicine packaging before dispensing it. The code is checked against the Estonian database system managed by REKS (hereinafter REKS database system). The code can be checked either with a scanner or by manually entering the data on the packaging.
The pharmacy needs to define the appropriate workflow to be followed when checking the authenticity of the medicine and deactivating the security tag. For example, whether the medicine needs to be scanned also upon arrival at the pharmacy or only when the medicine is sold with deactivation, actions to be taken in the event of suspected counterfeiting, etc.
If the end user is unable to verify the authenticity or deactivation of 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 package can be deactivated later.
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 .
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 .
Contract with REKS
The pharmacy 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 REKS an e-mail: 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 medications without checking their authenticity (in such a case, the pharmacist must retain the code information in order to check and deactivate them later when the system is restored).
Interfacing the pharmacy information system with the REKS database
The pharmacy can interface its 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 pharmacy 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.
It is recommended that pharmacies 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 pharmacy. The administrator can manage all users in their 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!
Using the free REKS online solution
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.