html5-img
1 / 17

FAMHP

DG PRE. DG POST. DG INSPECTION. FAMHP. 3 “cornerstones” of the Agency. Special Investigation Unit. SOE. R&D (human). Post Registration (humane + veterinary). Control Policy. Registration (human). Vigilance

sherlock
Download Presentation

FAMHP

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 1

  2. DG PRE DG POST DG INSPECTION FAMHP 3 “cornerstones” of the Agency Special Investigation Unit SOE R&D (human) Post Registration (humane + veterinary) Control Policy Registration (human) Vigilance (Pharmacovigilance human + veterinary, bio-, materio-, hemovigilance) Industry Veterinary Medicines (R&D, registration) Delivery Health Products Evaluation (quality, safety, effectiveness) Correct Usage 2

  3. Serialization : what good is it? • Serialization : Uniquely numbering each and every pack • Identification : serial vs. random • Electronic pedigree : track & trace • Electronic pedigree : full traceability or end to end • Manufacturers • Wholesalers • Pharmacies/retail • link between serial # and real-time information? • Should extra data be added (expiry date, batch nbr.) • Can also apply to “clusters” 3

  4. Current situation : Belgium • Serialization on reimbursed medicinal products • Backwards compatible with CNK numbering scheme • End to end traceability for reimbursment purposes • But also used by private corporations (Aegate) Manufacturer Issues serial # List of assigned # RIZIV/INAMI reimbursment Consistency Check scanned Vs. issued barcode Pharmacist scans Pack and serial # Tarification Office (monthly) List of scanned # Reimbursment 4

  5. Current situation : Other countries • Italy (Bolloni), Spain, France, Greece, Turkey,… • Have established or are establishing serialization projects • Important for future developments : systems have been established, often at considerable cost, how to maintain them in the future scheme of things 5

  6. Current Situation : Numbering schemes 6

  7. Future developments : Counterfeit Directive • Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source • Brokering • Active substances • Safety features • Repackaging • Inspection • Pharmacovigilance • … 7

  8. Counterfeit Directive : Commission proposal • 8) In Article 54, the following point (o) is added: • ‘(o) safety features making it possible to ascertain identification, authenticity and traceability of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI.’ • 9) The following Article 54a is added: • ‘Article 54a • (1) The safety features referred to in point (o) of Article 54 shall allow wholesale distributors or pharmacists or persons authorised or entitled to supply medicinal products to the public to perform all of the following: • (a) verify authenticity by assessing overt, covert, or forensic devices; • (b) identify individual packs; • (c) verify whether the outer packaging has been tampered with. • … 8

  9. Counterfeit Directive : Commission proposal • (4) The Commission shall adopt the measures necessary for the implementation of point (o) of Article 54 and of paragraphs (1) and (2) of this Article. • Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 121(2a) • When adopting those measures, the Commission shall consider the risk related to products or categories of products and at least all of the following: • the price and sales volume of the product; • (b) the number of incidences of falsifications in third countries and within the Community; • (c) the evolution of those incidences in the past; • (d) the specific characteristics of the products concerned • (e) the severity of the conditions intended to be treated • On the basis of these criteria, the requirements referred to in points (a) and (b) of pararaph(1) of this Article may be waived for certain products or product categories • The measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights. 9

  10. Counterfeit Directive : Current situation • No traceability • Safety features serving as tampering-evidence • Not “Prescription medicines” only, but based on risk analysis • Implementation by delegated acts • Product categories at risk : “other potential risks to public health” • Procedures for communication Competent authority – Commission • Technical specifications for safety features • Provisions to extend the use of safety features to purposes for national provisions, as e.g. reimbursment. • Extension for Art. 80 : requirement to record all batch numbers? 10

  11. Counterfeit Directive : the details • http://register.consilium.europa.eu posts regular updates on the proceedings regarding this new legislation. 11

  12. Counterfeit Directive : what’s next? • Amendements from European Parliament (e.g. internet) • Under discussion…. • Work will continue under Belgian Presidency 12

  13. Council of Europe Convention • “Council of Europe convention on counterfeiting of medicinal products and similar crimes involving threats to public health.” 13

  14. Council of Europe Convention • No specific measures • Chapter V – Measures for prevention • Article 18 – Preventive measures • Each Party shall adopt such legislative or other measures as may be necessary to establish the quality and safety requirements of medical products. • Each Party shall adopt such legislative or other measures as may be necessary to ensure the safe distribution of medical products. • With the aim of preventing counterfeiting of medical products, active substances, excipients, parts, materials and accessories, each Party shall take the necessary measures to provide, inter alia, for: • training of health care professionals, providers, police and customs authorities as well as relevant regulatory authorities; • the promotion of awareness raising campaigns addressed to the general public providing information about counterfeit medical products; • the prevention of illegal supplying of counterfeit medical products, active substances, excipients, parts, materials and accessories. 14

  15. Council of Europe : EDQM project • However… • EDQM Track & Trace project : • Uniform serialisation across Europe (and other countries) • Full Track & trace • Real time checking through a centralised/distributed database. 15

  16. Conclusion • No clear position yet • Different solutions are being/shall be explored • Choices will have to be made • Technology (2D code, RFID, 1D Code)? • How much traceability? • Retain backwards compatibility? • Rich barcodes (expiry date, lotnr) or lean barcodes with rich backend (database)? • Scope of products, possible voluntary extension of scope (e.g. to allow the patient to check his product via smartphone camera)? • Implications for production/packaging lines • … 16

  17. Thank you! • Philippe De Buck, • Philippe.debuck@fagg.be • Federal Agency for Medicines and Health Products • Place Victor Horta 40/40 • 1060 Brussels, • Belgium 17

More Related