Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products: A Manual for Drug Regulatory Authorities - Regulatory Support Series No. 005
(1998; 213 pages)
Índice de contenido
Ver el documentoPREFACE
Ver el documentoI. INTRODUCTION
Abrir esta carpeta y ver su contenidoII. PROVISIONS AND PREREQUISITES FOR REGULATORY CONTROL
Abrir esta carpeta y ver su contenidoIII. OPERATING ACTIVITIES
Abrir esta carpeta y ver su contenidoIV. REVIEW OF APPLICATIONS FOR MARKETING AUTHORIZATION OF MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS
Ver el documentoV. ISSUE OF WRITTEN MARKETING AUTHORIZATION
Ver el documentoVI. VARIATIONS
Ver el documentoVII. PERIODIC REVIEWS
Ver el documentoVIII. SUSPENSION AND REVOCATION OF MARKETING AUTHORIZATION
Ver el documentoGLOSSARY
Ver el documentoABBREVIATIONS
Ver el documentoREFERENCES
Cerrar esta carpetaANNEXES
Abrir esta carpeta y ver su contenidoAnnex 1: National drug regulatory legislation: guiding principles for small drug regulatory authorities1
Cerrar esta carpetaAnnex 2: *Guidelines for Implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce1
Ver el documento1. Provisions and objectives
Ver el documento2. Eligibility for participation
Ver el documento3. Requesting a certificate
Ver el documento4. Issuing a certificate
Ver el documento5. Notifying and investigating a quality defect
Ver el documentoReferences
Ver el documentoAppendix 1. Model Certificate of a Pharmaceutical Product
Ver el documentoAppendix 2. Model Statement of Licensing Status of Pharmaceutical Product(s)
Ver el documentoAppendix 3. Model Batch Certificate of a Pharmaceutical Product
Ver el documentoAppendix 4. Glossary and index (not intended to be a formal part of the Scheme).
Abrir esta carpeta y ver su contenidoAnnex 3: *Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability1
Ver el documentoAnnex 4: Model Guidelines on Conflict of Interest and Model Proforma for a Signed Statement on Conflict of Interest
Ver el documentoAnnex 5: Model Contract between a Regulatory Authority and an External Evaluator of Chemistry, Pharmaceutical and Bioavailability Data
Ver el documentoAnnex 6: Model Application Form for new Marketing Authorizations, Periodic Reviews and Variations, with Notes to the Applicant
Ver el documentoAnnex 7: Detailed Advice on Evaluation of Data by the Drug Regulatory Authority
Abrir esta carpeta y ver su contenidoAnnex 8: Ethical criteria for medicinal drug promotion1
Ver el documentoAnnex 9: Model marketing authorization letter
Ver el documentoAnnex 10: Model List of Variations (Changes) to Pharmaceutical Aspects of Registered Products which may be made without Prior Approval
Abrir esta carpeta y ver su contenidoAnnex 11: *Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms1
 

5. Notifying and investigating a quality defect

5.1 Each certifying authority undertakes to institute enquiries into any quality defect reported in a product exported in accordance with the provisions of the Scheme, on the understanding that:

- the complaint is transmitted, together with the relevant facts, through the competent authority in the importing country;

- the complaint is considered to be of a serious nature by the latter authority; and

- the defect, if it appeared after delivery of the product into the importing country, is not attributable to local conditions.

5.2 In the case of obvious doubt, a participating national authority may request WHO to assist in identifying an independent quality control laboratory to carry out tests for the purposes of quality control.

5.3 Each certifying authority undertakes to inform WHO and, as far as is possible, all competent national authorities, of any serious hazard newly associated with a product exported under the provisions of the Scheme or of any criminal abuse of the Scheme directed, in particular, to the export of falsely labelled, spurious, counterfeited or substandard pharmaceutical products. On receipt of such notification, WHO will transmit the message immediately to the competent national authority in each Member State.

5.4 WHO stands prepared to offer advice should difficulty arise in implementing any aspect of the Scheme or in resolving a complaint, but it cannot be a party to any resulting litigation or arbitration.

Ir a la sección anterior Ir a la siguiente sección
 

Última actualización: le 3 mayo 2013