Each party recognizes that the importing country has a right to fulfill its legal responsibilities by taking actions necessary to ensure the protection of human and animal health at the level of protection it deems appropriate. This includes the suspension of the distribution, product detention at the border of the importing country, withdrawal of the batches and any request for additional information or inspection as provided in Sec. 26.12.
Sec. Appendix A to Subpart A of Part 26--List of Applicable Laws,
Regulations, and Administrative Provisions
1. For the European Community (EC):
[Copies of EC documents may be obtained from the European Document Research, 1100 17th St. NW., suite 301, Washington, DC 20036. EC documents may be viewed on the European Commission Pharmaceuticals Units web site at http://dg3.eudra.org.]Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation, or administrative action relating to proprietary medicinal products as extended, widened, and amended.Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products as extended, widened and amended.Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products, as widened and amended.Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use. Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.Council Regulation EEC No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use.Guide to Good Distribution Practice (94/C 63/03).Current version of the Guide to Good Manufacturing Practice, Rules Governing Medicinal Products in the European Community, Volume IV.
2. For the United States:
[Copies of FDA documents may be obtained from the Government Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents, except the FDA Compliance Program Guidance Manual, may be viewed on FDA's Internet web site at http://www.fda.gov.]Relevant sections of the United States Federal Food, Drug, and Cosmetic Act and the United States Public Health Service Act.Relevant sections of Title 21, United States Code of Federal Regulations (CFR) Parts 1-99, Parts 200-299, Parts 500-599, and Parts 600-799.Relevant sections of the FDA Investigations Operations Manual, the FDA Regulatory Procedures Manual, the FDA Compliance Policy Guidance Manual, the FDA Compliance Program Guidance Manual, and other FDA guidances.
Sec. Appendix B to Subpart A of Part 26--List of Authorities 1. For the United States: In the United States, the regulatory authority
is the Food and Drug Administration. 2. For the European Community: In the European Community, the regulatory
authorities are the following: Belgium: Inspection g[eacute]n[eacute]rale de la Pharmacie, Algemene Farmaceutische Inspectie.Denmark: Laegemiddelstyrelsen.Germany: Bundesministerium f[uuml]r Gesundheit for immunologicals: Paul-Ehrlich-Institut, Federal Agency for Sera and Vaccines.Greece: [Epsi][theta][nu][iota][kappa][omega][sigmav] [Omega][rho][gamma][alpha][nu][iota][sigma][mu][omega][sigmav] [Phi][alpha][rho][mu][alpha][kappa][omega][upsi], Ministry of Health and Welfare, National Drug Organization (E.O.F).Spain: For medicinal products for human use: Ministerio de Sanidad y Consumo, Subdirecci[oacute]n General de Control Farmac[eacute]utico. For medicinal products for veterinary use: Ministerio de Agricultura, Pesca y Alimentaci[oacute]n (MAPA), Direcci[oacute]n General de la Producci[oacute]n Agraria.France: For medicinal products for human use: Agence du M[eacute]dicament. For veterinary medicinal products: Agence Nationale du M[eacute]dicament V[eacute]t[eacute]rinaire.Ireland: Irish Medicines Board.Italy: For medicinal products for human use: Ministero della Sanit[agrave], Dipartimento Farmaci e Farmacovigilanza. For medicinal products for veterinary use: Ministero della Sanit[agrave], Dipartimento alimenti e nutrizione e sanit[agrave] pubblica veterinaria-Div. IX.Luxembourg: Division de la Pharmacie et des M[eacute]dicaments.Netherlands: Staat der Nederlanden.Austria: Bundesministerium f[uuml]r Arbeit, Gesundheit und Soziales.Portugal: Instituto da Farm[aacute]cia e do Medicamento (INFARMED).Finland: L[auml][auml]kelaitos/L[auml]kemedelsverket (National Agency for Medicines).Sweden: L[auml]kemedelsverket-Medical Products Agency.United Kingdom: For human use and veterinary (non-immunologicals): Medicines Control Agency. For veterinary immunologicals: Veterinary Medicines Directorate.European Community: Commission of the European Communities. European Agency for the Evaluation of Medicinal Products (EMEA).
Sec. Appendix C to Subpart A of Part 26--Indicative List of Products
Covered by Subpart A Recognizing that precise definition of medicinal products and drugs are to be found in the legislation referred to above, an indicative list of products covered by this arrangement is given below:
--human medicinal products including prescription and nonprescription drugs;
--human biologicals including vaccines, and immunologicals;
--veterinary pharmaceuticals, including prescription and nonprescription drugs, with the exclusion of veterinary immunologicals (Under 9 CFR 101.2 ``veterinary immunologicals'' are referred to as ``veterinary biologicals'');
--premixes for the preparation of veterinary medicated feeds (EC), Type A medicated articles for the preparation of veterinary medicated feeds (United States);
--intermediate products and active pharmaceutical ingredients or bulk pharmaceuticals (United States)/starting materials (EC).
Sec. Appendix D to Subpart A of Part 26--Criteria for Assessing
Equivalence for Post- and Preapproval
I. Legal/Regulatory authority and structures and procedures providing
for post- and preapproval: A. Appropriate statutory mandate and jurisdiction.B. Ability to issue and update binding requirements on GMP's and guidance documents.C. Authority to make inspections, review and copy documents, and to take samples and collect other evidence.D. Ability to enforce requirements and to remove products found in violation of such requirements from the market.E. Substantive current good manufacturing requirements.F. Accountability of the regulatory authority.G. Inventory of current products and manufacturers.H. System for maintaining or accessing inspection reports, samples and other analytical data, and other firm/product information relating to matters covered by subpart A of this part. II. Mechanisms in place to assure appropriate professional standards and
avoidance of conflicts of interest.
III. Administration of the regulatory authority: A. Standards of education/qualification and training.B. Effective quality assurance systems measures to ensure adequate job performance.C. Appropriate staffing and resources to enforce laws and regulations.
IV. Conduct of inspections: A. Adequate preinspection preparation, including appropriate expertise of investigator/team, review of firm/product and databases, and availability of appropriate inspection equipment.B. Adequate conduct of inspection, including statutory access to facilities, effective response to refusals, depth and competence of evaluation of operations, systems and documentation; collection of evidence; appropriate duration of inspection and completeness of written report of observations to firm management.C. Adequate postinspection activities, including completeness of inspectors' report, inspection report review where appropriate, and conduct of followup inspections and other activities where appropriate, assurance of preservation and retrieval of records.
V. Execution of regulatory enforcement actions to achieve corrections,
designed to prevent future violations, and to remove products found in
violation of requirements from the market.
VI. Effective use of surveillance systems: A. Sampling and analysis.B. Recall monitoring.C. Product defect reporting system.D. Routine surveillance inspections.E. Verification of approved manufacturing process changes to marketing authorizations/approved applications.
VII. Additional specific criteria for preapproval inspections: A. Satisfactory demonstration through a jointly developed and administered training program and joint inspections to assess the regulatory authorities' capabilities.B. Preinspection preparation includes the review of appropriate records, including site plans and drug master file or similar documentation to enable adequate inspections.C. Ability to verify chemistry, manufacturing, and control data supporting an application is authentic and complete.D. Ability to assess and evaluate research and development data as scientifically sound, especially transfer technology of pilot, scale up and full scale production batches.E. Ability to verify conformity of the onsite processes and procedures with those described in the application.F. Review and evaluate equipment installation, operational and performance qualification data, and evaluate test method validation.
Sec. Appendix E to Subpart A of Part 26--Elements To Be Considered in
Developing a Two-Way Alert System
1. Documentation --Definition of a crisis/emergency and under what circumstances an alert is required--Standard Operating Procedures (SOP's)--Mechanism of health hazards evaluation and classification--Language of communication and transmission of information
2. Crisis Management System --Crisis analysis and communication mechanisms--Establishment of contact points--Reporting mechanisms
3. Enforcement Procedures --Followup mechanisms--Corrective action procedures
4. Quality Assurance System --Pharmacovigilance programme--Surveillance/monitoring of implementation of corrective action
5. Contact Points For the purpose of subpart A of this part, the contact points for the alert system will be:
A. For the European Community: the Executive Director of the European Agency for the Evaluation of Medicinal Products, 7, Westferry Circus, Canary Wharf, UK - London E14 4HB, England. Telephone 44-171-418 8400, Fax 418-8416.
B. For the United States : Biologics: Director, Office of Compliance and Biologics Quality (HFM-600), 1401 Rockville Pike, Rockville, MD 20852, phone: 301-827-6190, fax: 301-594-1944.Human Drugs: Director, Office of Compliance, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, phone: 301-796-3100, fax: 301-847-8747.Veterinary Drugs: Director, Office of Surveillance and Compliance (HFV-200), MPN II, 7500 Standish Pl., Rockville, MD 20855-2773, phone: 301-827-6644, fax: 301-594-1807. [63 FR 60141, Nov. 6, 1998, as amended at 69 FR 48775, Aug. 11, 2004; 74 FR 13112, Mar. 26, 2009]