1. Mark Cilia Director Inspectorate & Enforcement 7 th May, 2014 Medicines Authority 203,Level 3, Rue D’Argens, Gzira,GZR 1368 Tel: (+356) 2343 9000 Fax: (+356) 2343 9161 Email: info.medicinesauthority@gov.mt Medicines Authority: Activities & Functions Stakeholders’ Information session on FMD: Safety features

2. Medicines Authority: Activities & Functions FMD : Safety Features The Falsified Medicines Directive (FMD) – Directive 2011/62/EU - stipulates that: Prescription medicines shall bear the safety features. Non-prescription medicines shall not bear the safety features. The Directive provides for lists of exceptions from the general rule to be set by COM on the basis of risk of and arising from falsification.

3. Medicines Authority: Activities & Functions FMD : Safety Features FMD establishes the Safety Features: Safety features = Unique Identifier (UI) namely a serialisation number; Anti-tampering Device (ATD)

4. Medicines Authority: Activities & Functions Safety Features Delegated Act Directive 2011/62/EU requires the Commission to set the detailed rules, technical characteristics and modalities of verification of the safety features via a delegated act. The delegated act / regulation will provide for: Technical characteristics of the UI; Verification of the SF; Repository for the UI; Lists of exceptions from bearing/not bearing the safety features; Procedures for notification of exceptions by MS.

5. Medicines Authority: Activities & Functions Safety Features : Impact Assessment COM conducted an Impact Assessment on: 1. The technical characteristics of the unique identifier (i.e.: composition of the UI? format of the barcode holding the UI?); 2. The options for the verification of the authenticity of the safety features (i.e.: who will check the barcode? When?); 3. The technical options for establishing and managing the repository system (i.e.: who will establish and manage the database?).

6. Medicines Authority: Activities & Functions Safety Features : Unique Identifier Composition Following the IA COM established the following: Technical Characteristics / Composition of the Unique Identifier(UI) There should be harmonisation of the composition of the number and the data carrier.  The UI should contain the following information: Manufacturer product code; Serial number; A national reimbursement number in those MS if present; Batch number; Expiry date.  The UI will be carried by a 2D barcode (data matrix).

7. Medicines Authority: Activities & Functions Safety Features : Verification Systematic verification of the safety features at the dispensing point and risk- based verification by wholesale distributors:  Medicines will be systematically checked-out at the dispensing point;  Wholesale distributors will verify the safety features when: The product is not obtained from the holder of the manufacturing authorisation or the holder of the marketing authorisation; The product is returned by another wholesale distributor or a pharmacy. So there will be a systematic check-in (at manufacturing stage) with a systematic check-out (at dispensation stage) of the UI from the system, with some checks in between. Verification of the safety features

8. Medicines Authority: Activities & Functions Safety Features : Repository System Set up and management of the repository system Establishment and management by stakeholders. FMD specifies the manufacturing authorisation holders. However the repository system must have :  supervision by the relevant competent authorities;  interoperability.

9. Medicines Authority: Activities & Functions Safety Features : Summary In summary, the Commission intends to propose in the delegated acts: Harmonisation of the composition of the UI and the data carrier; Systematic verification of the safety features at the dispensing point and risk-based verification by wholesale distributors; Establishment and management by stakeholders with supervision by the relevant competent authorities.

10. Medicines Authority: Activities & Functions Safety Features : Exceptions The FMD specifies that: Prescription medicines (POMs) by default shall bear the safety features. Non-prescription medicines (OTCs) by default shall not bear the safety features. However the FMD provides for lists of exceptions from the general rule to be set by COM on the basis of risk of and arising from falsification. So there can be a list of exceptions whereby: - POM are exempted from the SF (a.k.a. ‘white list’) and, - OTCs are required to have the SF (a.k.a. ‘black list’).

11. Medicines Authority: Activities & Functions Safety Features : Exceptions (continued) The FMD lists that there can be exceptions for POM which must carry the safety features and OTC which shall not carry such safety features. However these are exceptions and COM is very clear that the lists will be as short as possible since these are exceptions. COM specified that: There will be one 'white' list and one 'black' list (no MS-specific lists); Lists populated on the basis of risk of and arising from falsification; Criteria for assessing the risk are set by the FMD; MSs can propose to COM products to be considered as exceptions based on the detailed application of these criteria as set by COM, but then only COM will decide whether to include or not in the lists; The lists will be included in the delegated act; MS can extend the scope of the UI to all reimbursed medicines, and of the ATD to all medicines.

12. Medicines Authority: Activities & Functions Way Forward Next Steps The Commission is drafting the delegated acts (Regulations) taking into account the cost effective options identified by the IA exercise. Meetings are held with MS and stakeholders’ representatives at EU Level for information and consultation; The adoption of the act is planned for end of 2014, with publication in the OJ following in the first half of 2015. MS which do not have a SN/UI for national reimbursement purposes have 3 years to implement the delegated act regulations from the date of their publication.

13. Medicines Authority: Activities & Functions Questions?

14. The information has been provided with generosity by experts in their field and is the property of the Medicines Authority. You are free to re-use the resources for non-profit use, as long as you do not infringe the Authority’s rights. If you are unsure whether you can use or re-use the material presented or their parts, please contact: Name: Mark Cilia Tel: 23439119 Thank You