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FAMHP
3 cornerstones of the Agency
Special Investigation Unit
SOE
RD (human)
Post Registration (humane veterinary)
Control Policy
Registration (human)
Vigilance (Pharmacovigilance human veterinary,
bio-, materio-, hemovigilance)
Industry
Veterinary Medicines (RD, registration)
Delivery
Health Products
Evaluation (quality, safety, effectiveness)
Correct Usage
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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

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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
RIZIV/INAMI reimbursment
List of assigned
Consistency Check scanned Vs. issued barcode
Pharmacist scans Pack and serial
Tarification Office (monthly)
List of scanned
Reimbursment
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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

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Current Situation Numbering schemes
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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

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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.

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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.

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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?

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Counterfeit Directive the details

• http//register.consilium.europa.eu posts regular
  updates on the proceedings regarding this new
  legislation.

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Counterfeit Directive whats next?

• Amendements from European Parliament (e.g.
  internet)
• Under discussion.
• Work will continue under Belgian Presidency

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Council of Europe Convention

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

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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.

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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/distribut
  ed database.

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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

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