PHARMACEUTICAL PRODUCT REGULATORY OFFICE
Manufacturing Site Registration/ Renewal Check List
1. Covering letter from the local agent in Bahrain signed and stamped.
2. Letter from the company indicating the name and address of the
manufacturing site and clarifying the relation between them (Company
letter head, signed &stamped).
3. Letter from the company declaring the name of the medicine (s) released
from this site (Registered or to be submitted for registration).
4. Letter from the company confirming that the submitted site is responsible
for the final release & if there is another site involved in the actual release
it must be mentioned.
5. Manufacturing site registration/renewal form.
6. Copy of valid GCC Central or SFDA manufacturing site registration
certificate. (If the applicant can’t comply with this requirement then valid
GMP inspection is required from competent authority*).
7. GMP certificate from the Health authority in the country of origin (If the
country of origin is not one of the competent authority listed below the
GMP must be legalised ) .
8. Copy of valid Manufacturing License.
9. Proof of payment of the application fee (not refundable in case of
rejection).
* Competent authorities (Health Authority in USA, Australia, New Zealand, Switzerland, Japan, Europe, Canada)
For Internal Use Only:
I declare that I have received the documents and materials confirmed in the above Checklist
Name :
Date :
Signature :
Comments :
PPR0015
OCT 2014
Ver.2
1