Regulatory Affairs · Short notes

Import and Export Control: Short Notes & Cheat Sheet

Rules for importing finished drugs and raw materials, controlled substances, and the certificates used for exporting medicines.

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Short notes

Read these before you attempt the topic's MCQs.

Import and export at a glance

Registration is the usual gateway; everything else is an exception needing special permission.

Imports

Imports are governed by the Drugs (Import and Export) Rules made under the Drugs Act 1976.
Normally only registered drugs may be imported for sale.
Unregistered drugs can be imported only with special DRAP permission, for example for personal use by a named patient, clinical trials, or urgent public-health needs.
Active ingredients and excipients for local manufacture are imported with DRAP permission against the licensed manufacturer's needs.
Imported consignments can be sampled and tested before release.

Controlled substances

Narcotic and psychotropic substances are also controlled by the Control of Narcotic Substances Act 1997.
They need separate import and export authorisations, within annual estimates reported to the International Narcotics Control Board (INCB).
Precursor chemicals (e.g. ephedrine and pseudoephedrine) are also tightly controlled, with quotas and records.

Exports

Pakistani manufacturers export to many countries, which usually require registration in the importing country.
DRAP issues a Certificate of Pharmaceutical Product (CoPP) under the WHO certification scheme, confirming the product's status and the site's GMP compliance.
Other export documents include a free sale certificate and a GMP certificate.
Exported products must meet both Pakistan's rules and the importing country's standards.

Cheat sheet

High-yield facts in one place. Cover the right-hand column and test yourself.

Documents

Document	Purpose
CoPP (WHO scheme)	Confirms product status and GMP of the maker
Free sale certificate	Product is legally sold in the home country
GMP certificate	Site complies with GMP
Import permission	Unregistered drug for a special purpose
Narcotic import/export authorisation	Controlled substances within INCB estimates

Laws and bodies

Item	Role
Drugs (Import and Export) Rules	Framework for drug imports and exports
Control of Narcotic Substances Act 1997	Narcotics and psychotropics
INCB	International estimates for controlled drugs
DRAP	Permissions, CoPP, testing of imports

Memory aids

CoPP = Certificate of Pharmaceutical Product: The WHO-scheme certificate that importing countries ask for; DRAP issues it for Pakistani exports.

Exam traps

Importing an unregistered drug for sale is not allowed without special permission.
Narcotics need authorisation under the Control of Narcotic Substances Act, not just DRAP registration.
A CoPP is issued by the exporting country's regulator, not the importing country's.
Precursor chemicals such as pseudoephedrine are controlled even though they are not narcotics.

Revised? Now test yourself.

Attempt the Import and Export Control MCQs while the notes are fresh. Anything you get wrong is saved to your incorrect list for the next revision round.