Import And Export Guidelines

Drug Regulatory Authority of Pakistan Import And Export Guidelines
Islamabad – Pakistan

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Imports and Exports of Therapeutic Goods

INTRODUCTION

Drug Regulatory Authority of Pakistan (DRAP) is responsible for ensuring that
therapeutic goods approved and available in market for the people of Pakistan must meet
the prescribed standards of quality, safety and efficacy. DRAP has a regulatory oversight
on import of all type of therapeutic goods to determine whether they are permittable in
accordance with the applicable drug laws. DRAP may refuse entry of any therapeutic
good in case of noncompliance to the regulatory requirements. These regulatory controls
are applied to prevent the infiltration of substandard and suspected falsified medicine into
the supply system and to assure the access to standard quality therapeutic goods. In some
cases, decisions are also taken to ensure the availability of unregistered / unavailable
therapeutic goods to the persons in need.
Infiltration of substandard and suspected falsified therapeutic goods poses serious threats
to the public health. In order to cope this challenge, DRAP in collaboration with the
Custom Authorities, Drug Control Organizations (DCO) and Health Departments of
Provincial Governments, has deployed administrative and regulatory controls to
safeguard public health.
The main objective of these guidelines is to provide legal and regulatory requirements to
importers and exporters of therapeutic goods, enabling them to comply with the
applicable drug laws for import and export of therapeutic goods. These guidelines specify
the format and content of the relevant applications and procedures to receive necessary
authorizations or permissions by DRAP.

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