Sop for Registration of drug for export purpose in Pakistan

	Company Name Regulatory affairs department Standard Operating Procedure
Title		PAGE NO. :
Post approval changes Registration of drug for export purpose

PREPARED BY :	DATE :	CHECKED BY :		DATE:	APPROVED BY :		DATE:
REGULATORY AFFAIRS OFFICER
CONTENT 1)    PURPOSE 2)    SCOPE 3)    REQUIRMENTS     1)    PURPOSE To provide detailed guidelines according to the Drug regulatory authority of Pakistan  2)        SCOPE To ensure that their companies comply with all of the regulations and laws pertaining to their business. To Work with federal, central, state, and local regulatory bodies and personnel on specific issues associated with their business, working with such agencies as the Food and Drug Administration, European Medicines Agency (pharmaceuticals and medical devices). To advise their company on the regulatory affairs and climate that would affect proposed activities. Describing the "regulatory climate" around issues like the promotion of prescription drugs compliance. 2 REQUIRMENTS. FOR LOCALLY MANUFACTURED PRODUCTS Registration of drug for export purpose. a. Application on Form 5 with required fee as per relevant SRO. b. NOC for CRF clearance. c. Copy of approved section from CLB. d. Copy of last inspection report. e. An undertaking that applied registration is exclusively for export purpose and Will not be sold in Pakistan. f. If formulation / product is not registered in Pakistan, then export order from Importing country.