Supplier Management and Outsourcing Falsification – new European legislation –
Supplier Management and Outsourcing Falsification – new European legislation – and how to prevent counterfeit medicines in the supply chain FDA/Xavier PharmaLINK Conference, March 2013 Cincinnati, USA Anne Junttonen Senior Pharmaceutical Inspector EU/EEA European Economic Area • Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland France Germany Lääkealan turvallisuus- ja kehittämiskeskus Greece Hungary Iceland Republic of Ireland Italy Latvia Liechtenstein Lithuania Luxembourg Malta March 12, 2013 Anne Junttonen The Netherlands Norway Poland Portugal Romania Slovakia Slovenia Spain Sweden UK EU agreements with non-EEA countries http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/documen t_listing/document_listing_000248.jsp&mid=WC0b01ac058005f8ac http://ec.europa.eu/enterprise/policies/single-market-goods/internationalaspects/acaa-neighbouring-countries/index_en.htm MRA ACAA Mutual Recognition Agreements • • • • • Switzerland Canada Australia New Zealand Japan (limited scope) Agreement on Conformity Assessment and Acceptance of Industrial Products • Israel (GMPs 19 Jan 2013) (USA not in operation) Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Supplier Management and Outsourcing - facts to note • Marketing Authorization MA of the Medicinal product defines all the manufacturing sites involved in the manufacturing of the API and the medicinal product, including the manufacturing site of release. • The importer into EEA and the release site must locate in the EEA and have a Manufacturing and Importation Authorization MIA. • Before release for supply the Qualified Person of the site of release must certify that the batch has been manufactured in accordance with the MA of the destination country, with EU GMPs, or equivalent, and any legal requiments of the releasing and the destination member states. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Supplier Management and Outsourcing The site of release is viewed as the actual Contract Giver and all the other players as Contract acceptors and subcontractors. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen The Qualified Person (Dir. 2001/83/EC) Articles 48 - 52 • Every MIA holder must have at least one QP • Defined Qualifications are required • The duties to ensure and certify batch compliance with GMP and MA, incl. safety feature, records of the certification • Actions to be taken by Members States Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Oursourcing (EU GMP Guide) (1) http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm Chapter 1 Pharmaceutical Quality System The regular Product Quality Review should include the review of contractual arrangements as defined in Chapter 7 to ensure that they are up to date. Chapter 7 Outsourced Activities • The Contract Giver should be responsible for reviewing and assessing the records and the results related to the outsourced activities. He should also ensure, either by himself, or based on the confirmation of the Contract Acceptor’s Qualified Person, that all products and materials delivered to him by the Contract Acceptor have been processed in accordance with GMP and the marketing authorisation. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Oursourcing (EU GMP Guide) (2) http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm Annex 16 Certification by a Qualified Person and Batch Release: • Each batch of finished product* must be certified by a Q.P. within the EEA before being released for sale or supply in the EEA or for export. • Manufacturing stages, including quality control QC testing, may be conducted at different sites and by different manufacturers. Each stage should be conducted in accordance with the relevant MA, GMP and the laws of the MS concerned, and should be taken into account by the Q.P. who certifies the finished product batch. • Certification need not be repeated on the same batch provided the batch has remained within the EEA. *in its final pack for release to the market. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Oursourcing (EU GMP Guide) (3) http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm Annex 16 Certification by a Qualified Person and Batch Release: • This Q.P. may need therefore to rely in part on the advice and decisions of others. Before doing so he should ensure that this reliance is well founded, either from personal knowledge or from the confirmation by other Q.P.s within a quality system which he has accepted. • This confirmation by other Q.P.s should be documented and should identify clearly the matters which have been confirmed. The systematic arrangements to achieve this should be defined in a written agreement. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Oursourcing (EU GMP Guide) (4) http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm Chapter 7 Outsourced Activities • the Contract Giver is responsible for assessing the legality*, suitability and the competence of the Contract Acceptor… • The Contract Acceptor should not subcontract to a third party … without the Contract Giver’s prior evaluation and approval…. Arrangements… should ensure that information and knowledge, including those from assessments of the suitability of the third party, are made available… • outsourced activities may be subject to inspections • Contract Giver must be permitted to audit outsourced activities, performed by the Contract Acceptor or his mutually agreed subcontractors. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Oursourcing (EU GMP Guide) (5) http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm Annex 16 Certification by a Qualified Person and Batch Release: • Unless a MRA is in operation samples from each batch should be tested in the EEA before certification of the finished product batch by a Q.P. • In order to represent the batch it may be preferable to take some samples during processing in the third country. For example, samples for sterility testing may best be taken throughout the filling operation. However in order to represent the batch after storage and transportation some samples should also be taken after receipt of the batch in the EEA. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Annex 16 is being revised to address the complicated supply chains Maybe something like this? The entire supply chain of the medicinal product, starting from the manufacturing sites of the starting materials and components, and including all actors involved in any manufacturing and importation activities of the medicinal product, is documented for each medicinal product, and available for the QP. The document should preferably be in the format of a comprehensive diagram, where each actor, including subcontractors of critical steps such as e.g. the sterilization of components and equipment for aseptic processing, are included. . Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Suppliers (EU GMP Guide) (1) http://ec.europa.eu/health/human-use/quality/developements/index_en.htm Draft Chapter 5: Production – public consultation on-going until 18 July 2013 • 5.26 The selection, qualification, approval and maintenance of suppliers of starting materials, together with their purchase and acceptance, should be documented as part of the pharmaceutical quality system. The level of supervision should be proportionate to the risks posed by the individual materials, taking account of their source, manufacturing process, supply chain complexity and the final use to which the material is put in the medicinal product. The supporting evidence for each supplier / material approval should be maintained. Staff involved in these activities should have a current knowledge of the suppliers, the supply chain and the associated risks involved. Where possible starting materials should be purchased directly from the manufacturer of the starting material. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Suppliers (EU GMP Guide) (2) http://ec.europa.eu/health/human-use/quality/developements/index_en.htm Draft Chapter 5: Production – public consultation on-going until 18 July 2013 (5.26) • The quality requirements established by the manufacturer for the starting materials should be discussed and agreed with the suppliers. Appropriate aspects of the production, and control, including handling, labelling, packaging and distribution requirements, complaints, recalls and rejection procedures should be documented in a quality agreement or specification. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Suppliers (EU GMP Guide) (3) http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm Chapter 4: Documentation 4.14 Specifications for starting and primary or printed packaging materials should include or provide reference to, if applicable: a) A description of the materials, including: - The designated name and the internal code reference; - The reference, if any, to a pharmacopoeial monograph; - The approved suppliers and, if reasonable, the original producer of the material; - A specimen of printed materials; b) Directions for sampling and testing; c) Qualitative and quantitative requirements with acceptance limits; Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Suppliers (EU GMP Guide) (4) http://ec.europa.eu/health/human-use/quality/developements/index_en.htm Draft Chapter 5: Production – public consultation on-going until 18 July 2013 5.27 For the approval and maintenance of suppliers of active substances and excipients, the following is required: Active substances • Supply chain traceability should be established and the associated risks, from active substance starting materials to the finished medicinal product, should be formally assessed and periodically verified. Appropriate measures should be put in place to reduce risks to the quality of the active substance. • The supply chain and traceability records for each active substance (including active substance starting materials) should be available and be retained by the EEA based manufacturer or importer of the medicinal product. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Suppliers (EU GMP Guide) (5) http://ec.europa.eu/health/human-use/quality/developements/index_en.htm Draft Chapter 5: Production – public consultation on-going until 18 July 2013 (5.27) • Audits should be carried out at the manufacturers and distributors of active substances… The holder of the manufacturing authorization shall verify such compliance either by himself or through an entity acting on his behalf under a contract. For veterinary medicinal products, audits should be conducted based on risk. • Audits should be of an appropriate duration and scope… The report should fully reflect what was done and seen on the audit with any deficiencies clearly identified. Corrective and preventive actions should be implemented. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Suppliers (EU GMP Guide) (6) http://ec.europa.eu/health/human-use/quality/developements/index_en.htm Draft Chapter 5: Production – public consultation on-going until 18 July 2013 (5.27) • Further audits should be undertaken at intervals defined by the quality risk management process to ensure the maintenance of standards and continued use of the approved supply chain. Excipients • Excipients which are considered to pose a particular risk to the quality of the medicinal product, based on formalised quality risk management, should be given similar attention to those for active substances. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Suppliers (EU GMP Guide) (7) http://ec.europa.eu/health/human-use/quality/developements/index_en.htm Draft Chapter 5: Production – public consultation on-going until 18 July 2013 5.28 For each delivery of starting material the containers should be checked for integrity of package, including tamper evident seal where relevant, and for correspondence between the delivery note, the supplier’s labels and approved supplier information maintained by the medicinal product manufacturer. The receiving checks on each delivery should be documented. 5.31 There should be appropriate procedures or measures to assure the identity of the contents of each container of starting material. Bulk containers from which samples have been drawn should be identified. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Suppliers (EU GMP Guide) (8) http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm ANNEX 8 SAMPLING OF STARTING AND PACKAGING MATERIALS • The identity of a complete batch of starting materials can normally only be ensured if individual samples are taken from all the containers and an identity test performed on each sample. It is permissible to sample only a proportion of the containers where a validated procedure has been established to ensure that no single container of starting material has been incorrectly labelled. ... • It is improbable that a procedure could be satisfactorily validated for: — starting materials supplied by intermediaries such as brokers where the source of manufacture is unknown or not audited; — starting materials for use in parenteral products. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Suppliers (EU GMP Guide) (9) http://ec.europa.eu/health/human-use/quality/developements/index_en.htm Draft Chapter 5: Production – public consultation on-going 5.33 Manufacturers of finished products are responsible for any testing of starting materials as described in the marketing authorisation dossier. They can utilise partial or full test results from the approved starting material manufacturer but must, as a minimum, perform identification testing of each batch themselves according to annex 8. … the following requirements should be fulfilled: • a) A formal agreement should be signed, according to chapter 7,… special attention should be paid to those related to the distribution conditions (transport, wholesaling, storage and delivery) in order to maintain the quality characteristics of the starting materials and to ensure that test results remain applicable to the delivered material Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Suppliers (EU GMP Guide) (10) http://ec.europa.eu/health/human-use/quality/developements/index_en.htm Draft Chapter 5: Production – public consultation on-going (5.33) • b) The finished product manufacturer should perform audits at appropriate intervals at the site(s) carrying out the testing (including sampling) of the starting materials in order to assure compliance with Good Manufacturing Practice and with the specifications and testing methods described in the Marketing Authorisation dossier. • c) The certificate of analysis provided by the starting material manufacturer should be signed by a designated person with appropriate qualifications and experience. This person should ensure that each batch has been manufactured and checked for compliance with the requirements of the formal agreement. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Suppliers (EU GMP Guide) (11) http://ec.europa.eu/health/human-use/quality/developements/index_en.htm Draft Chapter 5: Production – public consultation on-going (5.33) • d) The finished product manufacturer should have a significant experience in dealing with the starting material manufacturer including assessment of batches previously received and the history of compliance before reducing in-house testing. Any significant change in the manufacturing or testing processes should be considered. • e) The finished product manufacturer should also perform a full analysis at appropriate intervals and compare the results with the supplier’s certificate of analysis in order to check the reliability of the latter. Should this testing identify any discrepancy then an investigation should be performed and appropriate measures taken. The acceptance of certificate of analysis from the supplier should be discontinued until these measures are completed. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Suppliers (EU GMP Guide) (12) http://ec.europa.eu/health/human-use/quality/developements/index_en.htm Draft Chapter 5: Production – public consultation on-going until 18 July 2013 (5.33) Notes: • 1. A similar approach should apply to packaging materials as stated in GMP part I,… • 2. Identity testing of starting materials should be performed according to the methods and the specifications of the relevant Marketing Authorisation dossier. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Suppliers (EU GMP Guide) (13) http://ec.europa.eu/health/human-use/quality/developements/index_en.htm Draft Chapter 5: Production – public consultation on-going: 5.42 The purchase, handling and control of primary and printed packaging materials shall be accorded attention similar to that given to starting materials. 5.43 Particular attention should be paid to printed materials. .. stored in adequately secure conditions … avoid mix-ups. Packaging materials should be issued for use only by authorised personnel following an approved and documented procedure. …braille… Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Falsified Medicines Directive FMD 2007 cases of falsified medicinal products in the legal supply chain in some Member States 2008 heparin adulteration Dec 2008 Proposal published to amend the Medicines 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. July 2011 Falsified Medicines Directive (2011/62/EU) published Jan 2013 Directive entry into force in MSs with some exceptions regarding application deadlines. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Legal Proposal: 3 Pillars + 1 added by EP 1. Safety Features 2. 3. 4. Supply Chain Active Substances Internet Sale and Good Distribution Practices Lääkealan turvallisuus- ja kehittämiskeskus Anne MarchJunttonen 12, 2013 FMD: Definition of a Falsified medicinal product • Any medicinal product with a false representation of: a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients; b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or c) its history, including the records and documents relating to the distribution channels used. This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Falsified Medicines Directive 2011/62/EU (1) Applies only to commercial medicinal products for human use. Does not apply to Investigational Medicinal Products IMPs or veterinary medicines. Increased controls of APIs and excipients. Increased obligations on wholesale distributors and extending regulation to brokers of medicinal product. Provisions for introduction of medicines to EU territory for export - and not to be placed on EU market; e.g. in free trade zones and warehouses. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Falsified Medicines Directive 2011/62/EU (2) Requiring safety features on medicinal products at risk of falsification. Inspections e.g. of manufacturers, importers and distributors of APIs – also in 3. countries, manufacturers or importers of excipients, and of bokers. Addressing internet supply of medicinal products to the public. Penalties for falsification Product recall system down to patients. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Illegal Supply Chain • Medicines/pharmaceuticals/intermediates/ APIs/ are supplied and/or received by persons/players/actors with no legal entitlement • Out of ignorance or deliberately? • Awareness campaigns! Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Players in the legal Supply Chain • Marketing Authorization holders MAH FDM • API manufacturers, importers and distributors • Excipient manufacturers and importers • Medicinal Product manufacturers, inc. partial manufacturing/subcontractors, EEA importers, release testing laboratories, release site • Brokers of Medicinal product • Wholesale Distributors • Authorized/qualified/entitled suppliers of medicinal products to the public – including internet sales Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Legal API supply chain (1) FDM Manufacturers are defined in the MA with a ”QP Declaration”: A written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practice by conducting audits,… shall contain a reference to the date of the audit and a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good and for biological and/or sterile APIs: • GMP certificate by EEA competent authority - or in accordance with MRA, ACAA – entered into EudraGMDP database. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Legal API supply chain (2) FDM • … manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practices for active substances. • … the holder of the manufacturing authorisation shall verify compliance…. by conducting audits at the manufacturing and distribution sites of the manufacturer and distributors of active substances... either by himself or, without prejudice to his responsibility as provided for in this Directive, through an entity acting on his behalf under a contract. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen FMD: GDP for APIs DRAFT • GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE DRAFT SUBMITTED FOR PUBLIC CONSULTATION PUBLIC CONSULTATION until 30 April 2013 http://ec.europa.eu/health/files/gmp/2013-02_gdp_for_api_cons.pdf Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Legal API supply chain (3) FDM • Manufacturers, importers and distributors in EEA must be registered with the Competent Authority CA of the Member State MS where located – entry into EudraGMDP database. • CA of the MS concerned shall have a system of supervision including by inspections at an appropriate frequency based on risk, at the premises of the manufacturers, importers, or distributors of active substances, located on its territory, and effective follow-up thereof Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Legal API supply chain (4) FDM API shall only be imported (to EEA) if: • API manufactured in accordance with at least EU equivalent GMP • API accompanied by written confirmation from the CA of the exporting country on the GMP, supervision and prompt information sharing of Non-compliance issues regarding the manufacturing plant • Waivers form the Requirement of written confirmation: • The exporting country is included in the Commission’s list (“white list”). • Exceptionally to ensure the availability of medicinal products and when the plant has been inspected by a EEA CA – by a valid GMPc. To be applied July 2013. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen FMD: Importation of APIs QUESTIONS AND ANSWERS ON THE IMPORTATION OF ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE http://ec.europa.eu/health/files/gmp/2013_01_28_qa_en.pdf Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC http://ec.europa.eu/health/files/gmp/2013_01_28_template.pdf Third countries which have so far requested to be listed: Switzerland (approved), Australia, Japan, USA, Israel, Brazil, Singapore, Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen FMD: GMP of Excipients (1) • The holder of the manufacturing authorisation shall ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate good manufacturing practice is. This shall be ascertained on the basis of a formalised risk assessment... • … shall ensure that the appropriate good manufacturing practice so ascertained, is applied. The holder of the manufacturing authorisation shall document the measures taken under this paragraph; Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen FMD: GMP of Excipients (2) DRAFT GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS OF MEDICINAL PRODUCTS FOR HUMAN USE • PUBLIC CONSULTATION until 30 April 2013 http://ec.europa.eu/health/files/gmp/2013-02_guidelines_excipients_cons.pdf Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Medicinal Product manufacturing sites • including partial manufacturing e.g. contract manufacturers • Located in EEA: FDM • valid Manufacturing and Importation Authorization MIA entered into EudraGMDP database • Located outside EEA: • valid GMP certificate issued by EEA competent authority - or in accordance with MRA, ACAA - entered into EudraGMDP database Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen FMD: Medicinal Product Manufacturers • …to inform the competent authority and the marketing authorisation holder immediately if he obtains information that medicinal products which come under the scope of his manufacturing authorisation are, or are suspected of being, falsified irrespective of whether those medicinal products were distributed within the legal supply chain or by illegal means, including illegal sale by means of information society services; • … to verify that the manufacturers, importers or distributors from whom he obtains active substances are registered with the competent authority of the Member State in which they are established; • …to verify the authenticity and quality of the active substances and the excipients Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen FMD: Safety features (1) • for medicinal products other than radiopharmaceuticals • safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to: — verify the authenticity of the medicinal product, and — identify individual packs, as well as a device allowing verification of whether the outer packaging has been tampered with. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen FMD: Safety features (2) • …shall not be removed or covered, either fully or partially, unless the following conditions are fulfilled: • (a) the manufacturing authorisation holder verifies, prior to partly or fully removing or covering those safety features, that the medicinal product concerned is authentic and that it has not been tampered with; • (b) …replacing those safety features with safety features which are equivalent as regards the possibility to verify the authenticity, identification and to provide evidence of tampering of the medicinal product. … without opening the immediate packaging •… Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen FMD: Safety features (3) • Medicinal products subject to prescription shall bear the safety features…, unless they have been listed… • Medicinal products not subject to prescription shall not bear the safety features…, unless… they have been listed… after having been assessed to be at risk of falsification. • The Commission shall … detailed rules for the safety features... to be applied within 3 (or 6) years after the date of publication of the Commissions delegated acts Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen FMD: Safety features (4) • DELEGATED ACT ON THE DETAILED RULES FOR A UNIQUE IDENTIFIER FOR MEDICINAL PRODUCTS FOR HUMAN USE, AND ITS VERIFICATION PUBLIC CONSULTATION ON THE CONCEPT PAPER Ended April 2012. http://ec.europa.eu/health/files/counterf_par_trade/safety_2011-11.pdf Responses to the public consultation has been published: http://ec.europa.eu/health/humanuse/falsified_medicines/developments/2013-01_pc1_en.htm Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Wholesale distribution of medicinal products • All activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned (EU Medicines Directive 2001/83/EC). Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Wholesale Distributors • Wholesale Distribution authorization WDA entered into EudraGMDP database FDM • whether or not they physically handle the medicinal products; ”virtual” wholesalers • whenever on Union territory - including in areas such as free trade zones or free warehouses Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Revised EU GDP rules for medicinal products in the EU published March 8, 2013 introduces e.g. rules for • Quality Management, incl. QRM • appropriate management of suspected falsified medicinal products; • outsourced activities • qualification of suppliers and customers – and brokers • for transport in particular to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport; • for exporting • for brokers http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:068:0001:0014:EN:PDF Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen EU GDP Guide 5.9. Export to third countries • …person exporting medicinal products must hold a wholesale distribution authorisation or a manufacturing authorisation. This is also the case if the exporting wholesale distributor is operating from a free zone. • … they shall ensure that such supplies are only made to persons who are authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the country concerned. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Medicines Directive 2001/83/EG revised Article 85a as amended by Directive 2012/26/EU In the case of wholesale distribution of medicinal products to third countries,… wholesale distributors shall ensure that the medicinal products are obtained only from persons who are authorised or entitled to supply medicinal products in accordance with the applicable legal and administrative provisions of the third country concerned. …supplies are only made to persons who are authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the third country concerned. … Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen FMD: Brokering of Medicinal Products (1) Definition: • All activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen FMD: Brokering of Medicinal Products (2) • Only medicinal products covered by a marketing authorisation granted in EU • Register their activity with the competent authority of the MS where they are located; registration to be entered in a publicly accessible register. • Must have permanent address and contact details in EU • Must notify authorities of changes without delay Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Retail supply of Medicinal Products to the public • National legislation of EU Member states applies but • Sale of medicinal products to the public via the Internet: • The public should be assisted in identifying websites which are legally offering medicinal products for sale at a distance to the public. • awareness campaigns to warn of the risks of purchasing medicinal products from illegal sources via the Internet. Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen Retail supply of Medicinal Products to the public / FI National legislation • Only Finished Medicinal products – no intermediates, APIs, • Only by authorized pharmacies, hospital pharmacies and dispensaries (except for nicotine gum) • Distant sales e.g. internet sales only from authorized pharmacies within EEA. • There must always be a prescription when a prescription would be required in Fi. • No medicines from outside the EEA by mail! Lääkealan turvallisuus- ja kehittämiskeskus March 12, 2013 Anne Junttonen
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