The following activities are needed to be performed by pharmaceutical wholesalers in Estonian market to implement the requirements of the Falsified Medicines Directive (2011/62/EU) and the Delegated Regulation (2016/161) and to create the connection to Estonian National Medicines Verification System:
- Make sure that the organisation has an information system in use (for example a stock management software), which could be connected with the Estonian Medicines Verification System. The wholesaler is responsible for ordering the developments for the information system from the software provider.
- IT software provider needs to sign a non-disclose agreement (NDA) with REKS in order to be granted access to the software development kit (technical specifications) (find the NDA template here in Estonian and in English).
- Once the NDA is signed and sent to REKS the IT software provider has to register in the NMVS Software Supllier Portal (https://www.sws-nmvs.eu).
- REKS will then accept the registration and access to the technical specifications will be provided through the same portal. All specifications are only available through the portal to ensure the confidentiality of the information and to provide information about updates mades in documents.
- IT software providers are obliged to follow the technical specifications and requirements and to verify the quality of the developments once it is finished.
- Wholesalers are recommended to ask for a user guide or training from their IT software provider in regards to the changes made.
- Aquiring skanners, which read 2D codes. It is important to communicate with the IT software provider in regards to the models of available scanners because these should be integrated with the system to verify the medicines according to the codes on the package.
- It is important that wholesalers start with the necessary actvities as soon as possible in order to have the system put in place smoothly. The pilot of the Estonian system is planned during August-September 2018. By that time some of the wholesalers must already have the developments in their information system ready by the end of June to be able to connect to the Estonian Medicines Verification System and perfom testing.
- REKS will offer additional training to those wholesalers, which participate in the pilot.
- In case a wholesaler is interested in taking part of the pilot we ask to inform us by e-mail firstname.lastname@example.org.
- Wholesalers not taking part in the pilot must be connected to Estonian Medicines Verification System by the middle of October 2018.
- A summary meeting is planned for the end-users in October to provide information on the pilot results and the following timeplan of the system implementation.
- Signing a contract with REKS. This activity is planned in the second quarter of 2018.
- Determining resources for the new processes in the organisation (scanning or deactivating the safety features. Also, processes should be in place for when the verification of medicines is done, what are the activities in case there is a possible falsification is identified. There is no final decision on it in Estonia but it is allowed to decide in each member state, which are the entities for which the wholesalers must verify and decommission medicines on delivery (in case the entity is not able to perform the verification and decommission itself).
NB! End-users information system connection and the necessary developments for it is the responsibility of the end-user itself.