General procedures for drug export registration to various countries
A product can be marketed in international markets only after it is registered in that country. The registration approval is granted by the Health Authorities of the respective countries.
Registration process includes the following stages:
1. Health Authorities of many countries insist on company registration, which may also include plant inspection prior to product registration. Only after the company is registered, the Health Authorities consider products for registration.
For instance, in Vietnam and Bahrain for company registration, only submission of documents is essential whereas in some countries like Oman, Ethiopia for company registration, submission of documents as well as inspection is essential.
For Company registration following documents need to be submitted :
2. There are some other countries which do not insist on company registration but only plant approval. Inspections are conducted and a particular plant is approved for the specified dosage forms at that location. E.g. Tanzania, Uganda; South Africa, USA, etc.
Plant inspection is conducted by a team of experienced technical persons of the respective Health Authorities. During the inspection they see whether all the WHO-GMP requirements are fulfilled, whether the manufacturing facility, documents are as per latest pharmacopeial standards, etc.
3. In most of the countries, products are considered for registration directly. In these countries neither company registration is required nor plant approval is required. Every country has their own registration guidelines as per which the registration dossiers are submitted by the applicants.
The requirements for compilation of registration dossier are listed below :
Health authorities of some countries require manufacturing data in detail wherein process validation, Batch manufacturing records, Development studies are expected as part of the dossier, e.g. USA, South Africa, Singapore, etc.
In some countries analytical section is required extensively like inclusion of analytical method validation, TLC/HPLC/IR chromatograms. e.g. Thailand, Singapore, Philippines, etc.4. Re-registration of the product is done as per the validity schedule of the product in the country. Dossiers are submitted for re-registration as per the guidelines of the respective country.