Information for MAH
All pharmaceutical companies holding marketing authorization, both manufacturers as well as parallel importers, according to the Directive 2011/62/EU and Delegated Regulation EC 2016/161 are obliged to produce packaging bearing Safety Features. Safety Features are defined as:
- Unique Identifier
- Anti-Tampering Device
2D Data Matrix code is the Unique Identifier, the code will consist of such information as product code, serial number, batch number and expiry date.
Anti-Tampering Devices can take any form depending on the type of the external packaging, i.e.: perforated foil, hologram, band, suitable bottle cap, etc.
It is the responsibility of each producer and parallel importer to follow the registration process with European Medicines Verification Organization (EMVO) and get connected to the European Hub, which will allow the manufacturers to send the serialization data to the repository. The registration process is available through a dedicated EMVO website for individual MAH and for the group of MAHs associated under one capital group (On-Boarding Partner, OBP). EMVO offers a wide range of support for OBP during the registration process. All the details and guidelines are available here, the check list with all necessary information for the registration is here, a template of agreement with EMVO is here, the manual for the OBPs is here and the presentation there.
KOWAL Foundation is encouraging to start the registration process with EMVO without any delay, even if MAH is not fully prepared for the serialization process. Registration in EMVO is a process that may take some time, therefore, the earlier MAH register, the more certainty that the entire process will end before February 9, 2019.
Checklist for MAH
1. Registration of MAH with EMVO, signing the Participation Agreement, payment for connection to the EU Hub.
2. Take all necessary means to prepare your own production lines and start producing packs bearing Safety Features.
3. Registration of MAH with KOWAL Foundation (PLMVO), filling in the application at Foundation website or sending the e-mail to email@example.com.
4. Signing the Agreement on financing PLMVS and paying the fees based on received invoices.
5. Upload the data of serialized packs in PRD (production) enviroment.
MAH's fees for PLMVS
The KOWAL Foundation presents below basic information on the agreement defining the rules for financing the Polish Medicines Verification System by manufacturers and parallel importers distributing medicinal products bearing the safety features on Polish market (MAH).
The KOWAL Foundation, implementing the provisions of the Directive of the European Parliament and Council 2001/83/EC and Delegated Regulation (EU) 2016/161, by undertaking the obligation to establish the Polish Medicines Verification System (Polish System, PLMVS) in Poland. This obligation results directly from the law.
In accordance with the requirements of the Delegated Regulation (EU) 2016/161 supplementing Directive 2001/83/EC by laying down detailed rules for the safety features appearing on packaging of medicinal products for human use (Delegated Regulation), the costs of establishing and maintaining Polish System shall be borne by Market Autorisation Holders. This obligation also results directly from the law.
PLMVS will be an element of the European Medicines Verification System managed by the European Medicines Verification Organisation (the repositories system within the meaning of Article 32 (1) of the Delegated Regulation). The system stores information about safety features of the medicinal products allowing its verification. To provide information to the repositories system, MAH is obliged to sign the contract with KOWAL Foundation and make payment of fees stated in that contract.
According to the Delegated Regulation, the repositories system will operate from February 9, 2019. The obligation to use the repositories system in order to verify the authenticity of medicinal products distributed on the market by MAHs will arise from that date.
The amount of fees borne by MAH is a share in the overall cost of establishing and maintaining the repositories system falling to Poland, broken down by individual MAH.
The costs of an entrance fee is € 14,000 net, while from 2019 the annual fee is € 8,500 net. All amounts refer to the cost for one MAH.
Agreement for MAH on financing PLMVS
In order to finalize the cooperation the Agreement needs to be downloaded, filled in, signed and emailed to dedicated address: firstname.lastname@example.org.
We encourage you to familirized yourself with the Cover letter to the Agreement.
The KOWAL Foundation informs that the obligation to finance the construction and management of the PLMVS system rests with the MAHs, which is reflected in the provisions of the Agreement on financing PLMVS. This fact has recently been additionaly confirmed in the communicatio addressed by the European Commission and the European Medicines Agency to the MAHs and National Competent Authorities:https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/2018_letterstakeholders_safetyfeatures_en. pdf
The Agreement on financing PLMVS concluded between the entity representing MAHs listed in Appendix NO. 2 and KOWAL Foundation determines the payer of VAT invoices acting on behalf of MAHs listed therin. Therefore, VAT invoices to the Agreement are issued only to an entity that is a party to the Agreement on financing PLMVS.
Instructions for completing the Agreement
1. For the entities residing in Poland the Agreement must be filled in Polish, for the entities residing outside Poland the Agreement must be fill in English and voluntary in Polish.
2. To sign the Agreement the KOWAL Foundation is open to use OBP model presented by EMVO. It means that one of the MAH within the same capital group can sign the Agreement and enumerate (in the Appendix 2) all the MAHs on whose behalf the entry and annual fees will be paid. This solution is voluntary.
3. In order to sign the Agreement, it is obligatory to present a legally documented title to sign/power of attorney for the person signing the contract on behalf of MAH.
4. The completed and signed contract along with document confirming title to sign/power of attorney should be scanned and sent to: email@example.com.
5. After signing the contract by the KOWAL Foundation, the contract will be sent to the email address of the contact person provided in the Agreement.
6. No earlier than after 30 days from signing the Agreement by the Foundation, invoices for the entry fees will be issued and sent to the email address provided in the Agreement.
7. Invoices for the building and maintenance of PLMVS will be issued with a 30-day payment period.
8. In case of additional quarries please send us an e-mail: firstname.lastname@example.org.