ATTACHMENT G

In Annex 1, Product Sectors, Chapter 15, Medicinal products, GMP Inspection and Batch Certification should be deleted and replaced by the following:

‘CHAPTER 15

MEDICINAL PRODUCTS, GMP INSPECTION AND BATCH CERTIFICATION

Scope and coverage

The provisions of this Sectoral Chapter cover all medicinal products which are industrially manufactured and to which Good Manufacturing Practice (GMP) requirements apply.

For medicinal products covered by this Chapter, each party shall recognise the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations granted by the competent authorities of the other Party. This includes that each Party recognises conclusions of inspections of manufacturers in third countries carried out by the relevant inspection services of the other Party, inter alia, within the framework of the European Directorate for the Quality of Medicines & HealthCare (EDQM).

The Parties shall cooperate in order to achieve the best use of inspection resources by an appropriate burden sharing.

The manufacturer's certification of the conformity of each batch to its specifications shall be recognised by the other Party without re-control at import. To the products imported from a third country and further exported to the other Party this provision applies only (1) if each batch of the medicinal products has been subject to the re-control in the territory of one of the Parties; and (2) if the manufacturer in the third country has been subject to the inspection by the competent authority of either Party of which the outcome has been that for the products or products category the manufacturer complies with Good Manufacturing Practice. If the above conditions are not met, each Party can require a re-control in its territory.

In addition, official batch releases carried out by an authority of the exporting Party will be recognised by the other Party.

“Medicinal products” means all products regulated by pharmaceutical legislation in the European Union and Switzerland as listed in Section I of this Chapter. The definition of medicinal products includes all human and veterinary products, such as chemical and biological pharmaceuticals, immunologicals, radio-pharmaceuticals, stable medicinal products derived from human blood or human plasma, pre-mixes for the preparation of veterinary medicated feedingstuffs and, where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products.

“GMP” is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation and products specifications. For the purpose of this Chapter it includes the system whereby the manufacturer receives the specification of the product and the process from the marketing authorisation holder or applicant and ensures that the medicinal product is made in compliance with this specification.

With respect to medicinal products covered by the legislation of one Party but not the other, the manufacturing company can request, for the purpose of this Agreement, an inspection be made by the locally competent inspection service. This provision shall apply i.a. to the manufacture of active pharmaceutical ingredients, intermediate products and investigational medicinal products, as well as to pre-marketing inspections. Operational arrangements are detailed under Section III, paragraph 3.

Certification of manufacturers

At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision of the manufacture of medicinal products shall certify that the manufacturer:

— is appropriately authorised to manufacture the relevant medicinal product, or to carry out the relevant specified manufacturing operation,

— is regularly inspected by the authorities,

— complies with the national GMP requirements recognised as equivalent by the two parties, and which are listed in Section I of this Chapter. Should different GMP requirements be used as reference, this is to be mentioned in the certificate.

For inspections in third countries, at the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for the inspection shall certify that the manufacturer complies or does not comply with the GMP requirements recognised as equivalent by the two Parties, and which are listed in Section I of this Chapter.

The certificates shall also identify the site(s) of manufacture (and contract quality control laboratories, if any) and the date of the inspection.

Certificates shall be issued expeditiously, and the time taken should not exceed 30 calendar days. In exceptional cases, i.e. when a new inspection has to be carried out, this period may be extended to 90 days.

Batch certification

Each batch exported shall be accompanied by a batch certificate established by the manufacturer (self-certification) after a full qualitative analysis, a quantitative analysis of all the active ingredients and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation. This certificate shall attest that the batch meets its specifications and shall be kept by the importer of the batch. It will be made available upon request of the competent authority.

When issuing a certificate, the manufacturer shall take account of the provisions of the current WHO certification scheme on the quality of pharmaceutical products moving in international commerce. The certificate shall detail the agreed specifications of the product, the reference of the analytical methods and the analytical results. It shall contain a statement that the batch processing and packaging records were reviewed and found in conformity with GM P. The batch certificate shall be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Union the “qualified person” referred to in Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC, and in Switzerland the “responsible person” referred to in Articles 5 and 10 of the Ordinance on establishment licences.

Official Batch Release

When an official batch release procedure applies, official batch releases carried out by an authority of the exporting Party (listed in Section II) will be recognised by the other Party. The manufacturer shall provide the certificate of the official batch release.

For the European Union, the official batch release procedure is specified in document “Control Authority Batch Release of Vaccination and Blood Products, 2001” or subsequent versions and in different specific batch release procedures. For Switzerland, the official batch release procedure is specified in Article 17 of the Federal Law on medicinal products and medical devices and in Articles 18-21 of the Ordinance of the Swiss Agency for Therapeutic Products on the requirements for the marketing authorisation of medicinal products.

SECTION I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

SECTION II

Conformity assessment bodies

For the purpose of this Chapter “Conformity Assessment Bodies” means the official GMP inspection services of each Party.

The list of the official GMP Inspection Services of the Member States of the European Union and of Switzerland can be found below.

For conformity assessment bodies of the European Union:

Competent Authorities of the European Union are the following authorities of the Member States of the European Union or authorities succeeding them:

Country For medicinal products for human use For medicinal products for veterinary use Austria Austrian Agency for Health and Food Safety/Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH See responsible authority for human medicinal products Belgium Federal agency for medicines and health products/Federaal Agentschap voor geneesmiddelen en gezondheidsproducten/Agence fédérale des médicaments et produits de santé See responsible authority for human medicinal products Bulgaria Bulgarian Drug Agency/ ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА Bulgarian Food Safety Agency/ Българска агенция по безопасност на храните Cyprus Ministry of Health — Pharmaceutical Services/ Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας Ministry of Agriculture, Rural Development and Environment-Veterinary Services/ Κτηνιατρικές Υπηρεσίες- Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος Czech Republic State Institute for Drug Control/ Státní ústav pro kontrolu léčiv (SÚKL) Institute for State Control of Veterinary Biologicals and Medicaments/ Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL) Croatia Agency for Medicinal Products and Medical Devices/ Agencija za lijekove i medicinske proizvode (HALMED) Ministry of Agriculture, Veterinary and Food Safety Directorate/ Ministarstvo Poljoprivrede, Uprava za veterinarstvo i sigurnost hrane Denmark Danish Medicines Agency/ Laegemiddelstyrelsen See responsible authority for human medicinal products Germany Federal Institute for Drugs and Medical Devices/ Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Paul-Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines/Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel Federal Ministry of Health/Bundesministerium für Gesundheit (BMG)/Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) (1) Federal Office for Consumer Protection and Food Safety/ Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) Federal Ministry of Food and Agriculture, Bundesministerium für Ernährung und Landwirtschaft Estonia State Agency of Medicines/ Ravimiamet See responsible authority for human medicinal products Greece National Organisation for Medicines/ Ethnikos Organismos Farmakon (EOF) — (ΕΘΝΙΚΟΣ ΟΡΓΑΝΙΣΜΟΣ ΦΑΡΜΑΚΩΝ)) See responsible authority for human medicinal products Spain Spanish Agency of Medicines and Medical Devices/ Agencia Española de Medicamentos y Productos Sanitarios (2) See responsible authority for human medicinal products Finland Finnish Medicines Agency/ Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA) See responsible authority for human medicinal products France French National Agency for Medicines and Health Products Safety/Agence nationale de sécurité du médicament et des produits de santé (ANSM) French agency for food, environmental and occupational health safety-National Agency for Veterinary Medicinal Products/ Agence Nationale de Sécurité Sanitaire de l'alimentation, de l'environnement et du travail-Agence Nationale du Médicament Vétérinaire (Anses-ANMV) Hungary Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet/National Institute of Pharmacy and Nutrition National Food Chain Safety Office, Directorate of Veterinary Medicinal Products/Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI) Ireland Health Products Regulatory Authority (HPRA) See responsible authority for human medicinal products Italy Italian Medicines Agency/Agenzia Italiana del Farmaco Direction General for Animal Health and Veterinary Medicinal Products/ Ministero della Salute, Direzione Generale della Sanità Animale e dei Farmaci Veterinari Latvia State Agency of Medicines/ Zāļu valsts aģentūra Assessment and Registration Department of the Food and Veterinary Service/Pārtikas un veterinārā dienesta Novērtēšanas un reģistrācijas departaments Lithuania State Medicines Control Agency/ Valstybinė vaistų kontrolės tarnyba State Food and Veterinary Service/ Valstybinės maisto ir veterinarijos tarnyba Luxembourg Minìstere de la Santé, Division de la Pharmacie et des Médicaments See responsible authority for human medicinal products Malta Medicines Regulatory Authority Veterinary Medicines and Animal Nutrition section VMANS) (Veterinary Regulation Directorate (VRD) within the Veterinary and Phytosanitary Regulation Department (VPRD) Netherlands Healthcare Inspectorate/Inspectie voor de Gezondheidszorg (IGZ) Medicines Evaluation Board/ Bureau Diergeneesmiddelen, College ter Beoordeling van Geneesmiddelen (CBG) Poland The Main Pharmaceutical Inspectorate/ Główny Inspektorat Farmaceutyczny (GIF) See responsible authority for human medicinal products Portugal National Authority of Medicines and Health Products/ INFARMED, I.P Autoridade Nacional do Medicamento e Produtos de Saúde, I.P General Directorate of Food and Veterinary/DGAV — Direção Geral de Alimentação e Veterinária (PT) Romania National Agency for Medicines and Medical Devices/ Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale National Sanitary Veterinary and Food Safety Authority/Autoritatea Naţională Sanitară Veterinară şi pentru Siguranţa Alimentelor Sweden Medical Products Agency/Läkemedelsverket See responsible authority for human medicinal products Slovenia Agency for Medicinal Products and Medical Devices of the Republic of Slovenia/ Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) See responsible authority for human medicinal products Slovak Republic (Slovakia) State Institute for Drug Control/ Štátny ústav pre kontrolu liečiv (ŠÚKL) Institute for State Control of Veterinary Biologicals and Medicaments/ Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (USKVBL) United Kingdom Medicines and Healthcare products Regulatory Agency Veterinary Medicines Directorate

For Swiss conformity assessment bodies:

For all products for human and veterinary use:

http://www.swissmedic.ch/?lang=2

For the official batch release of immunobiological products for veterinary use:

http://www.blv.admin.ch/ivi/index.html?lang=en

SECTION III

Additional provisions

1. Transmission of inspection reports

Upon reasoned request, the relevant inspection services shall forward a copy of the last inspection report of the manufacturing site or, in case analytical operations are contracted out, of the control site. The request may concern a “full inspection report” or a “detailed report” (see item 2 below). Each party shall deal with these inspection reports with the degree of confidentiality requested by the providing Party.

Parties will ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 days should a new inspection be carried out.

2. Inspection reports

A “full inspection report” comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A “detailed report” responds to specific queries about a firm by the other Party.

3. GMP Reference

(a) Manufacturers shall be inspected according to the applicable GMP legislation listed in Section I.

(b) With respect to medicinal products covered by the pharmaceutical legislation of the importing Party but not the exporting country, the competent inspection service of the Party willing to carry out an inspection of the relevant manufacturing operations shall inspect according to its own GMP or, in the absence of specific GMP requirements, according to the applicable GMP of the importing Party. For specific products or classes of products (e.g. investigational medicinal products, starting materials not limited to active pharmaceutical ingredients), equivalence of GMP requirements shall be determined according to a procedure established by the Committee.

4. Nature of inspections

(a) Inspections shall routinely assess the compliance of the manufacturer with GM P. These are called general GMP inspections (also regular, periodic, or routine inspections).

(b) “Product- or process-oriented” inspections (which may be “pre-marketing” inspections as relevant) focus on the manufacture of one or a series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) shall be provided in confidence to the inspectorate.

5. Fees

The regime of inspection/establishment fees is determined by the manufacturer's location. Inspection/establishment fees shall not be charged to manufacturers located on the territory of the other Party.

6. Safeguard clause for inspections

Each Party reserves the right to have its own inspection conducted for reasons identified to the other Party. Such inspections are to be notified in advance to the other Party and shall, in accordance with Article 8 of this Agreement, be carried out jointly by the competent authorities of the two Parties. Recourse to this safeguard clause should be an exception.

7. Exchange of information on manufacturing/import authorisations and GMP compliance

The Parties shall exchange information on the authorisation status of manufacturers and importers and on the outcome of the inspections, in particular by entering authorisations, GMP certificates and information on GMP non-compliance into the database on GMP managed by the European Medicines Agency (EMA). GMP certificates and information on GMP-compliance shall follow the format in accordance with the procedures published by the EU.

In accordance with the general provisions of this Agreement, the parties shall exchange any information necessary for the mutual recognition of inspections and operation of this chapter.

The relevant authorities in Switzerland and in the European Union shall also keep each other informed of any new technical guidance or inspection procedure. Each Party shall consult the other before their adoption and shall endeavour to proceed towards their approximation.

8. Inspectors' training

In accordance with Article 9 of the Agreement, training sessions for inspectors, organised by the authorities, shall be accessible to inspectors of the other Party. The Parties to the Agreement shall keep each other informed on these sessions.

9. Joint inspections

In accordance with Article 12 of this Agreement, and by mutual agreement between the Parties, joint inspections may be organised. These inspections are intended to develop common understanding and interpretation of practice and requirements. The setting up of these inspections and their form shall be agreed through procedures approved by the Committee established under Article 10 of this Agreement.

10. Alert system

Contact points shall be agreed between both Parties to permit authorities and manufacturers to inform the authorities of the other Party with the appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the batch. A detailed alert procedure shall be agreed.

The Parties shall ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could have public health implications, are communicated to each other with the appropriate degree of urgency.

11. Contact points

For the purpose of this Agreement, the contact points for any technical question, such as exchanges of inspection reports, inspectors training sessions, technical requirements, are:

For the European Union The Director of the European Medicines Agency.

For Switzerland The official GMP inspection services listed in Section II above.

12. Divergence of views

Both Parties shall use their best endeavours to resolve any divergence of views concerning, inter alia, compliance of manufacturers and conclusions of inspection reports. Unresolved divergences of view will be referred to the Committee as established under Article 10 of this Agreement.’