Service overview
DRAP authorisations govern pharmaceutical manufacturing, product registration and certain related regulated activity.
Sector permissions are generally activity-, product-, facility- or location-specific. Some applications require technical studies, inspections, environmental clearance or preliminary consent from other bodies.
Who can apply for a drug manufacturing licence?
Identify the specific drug or production activity and applicable establishment, manufacturing and product permissions.
Drug manufacturers need a qualifying site, technical persons and GMP systems; a manufacturing facility licence does not by itself authorise marketing an unregistered drug product.
Documents and information for Drug Manufacturing and Product Registration Applications
Prepare the following information for drug manufacturing and product registration applications. The relevant regulator may require further forms or certified evidence, depending on the applicant and chosen procedure.
- Plant or site licences
- Quality-management and GMP documentation
- Formula and dossier
- Responsible technical staff
- Regulatory certificates.
How can a manufacturer obtain a DRAP drug manufacturing licence?
- 01Obtain DRAP site suitability/verification
Drug Manufacturing Licence process begins with verification of proposed manufacturing premises and required checklist.
- 02Secure DRAP layout plan approval
Prepare compliant GMP manufacturing/testing facilities drawings, utilities and controlled production areas.
- 03Apply on Form 1 for DML and complete inspection
After site/layout stages, submit Form 1 with technical personnel, plant and quality documentation; undergo DRAP inspection and Central Licensing Board scrutiny.
- 04Register specific drug products separately
A facility DML is distinct from product registration, including Form 5-F and other applicable marketing authorisation.
Regulator resource: DRAP site-layout-DML three-stage process
After registration or approval
Observe GMP, pharmacovigilance, labelling, batch controls and renewal obligations.
Governing law & official references
Drug Regulatory Authority of Pakistan Act, 2012 and the product, establishment and medical-device rules applicable to the activity.
The links below lead to government or official regulatory sources relevant to this service. Use the currently consolidated Act, regulations, statutory checklist and official portal when making an application.
How Chambers can assist
Chambers can review the legal route, identify regulatory constraints, prepare or review the supporting corporate and legal documents, manage the prescribed submission and correspond with the competent authority where instructed. The scope of the engagement will be determined by the applicant’s particular circumstances.
For an initial enquiry, identify the proposed activity, applicant entity and current stage, and provide the available documents indicated above. Please avoid sending confidential or identity-sensitive records through an unencrypted first contact.
Common questions about Drug Manufacturing and Product Registration Applications
Who is eligible for Drug Manufacturing and Product Registration Applications in Pakistan?
Identify the specific drug or production activity and applicable establishment, manufacturing and product permissions.
What documents are needed for Drug Manufacturing and Product Registration Applications?
Plant or site licences; Quality-management and GMP documentation; Formula and dossier; Responsible technical staff. Additional requirements can apply to the actual business or regulator.
How can a manufacturer obtain a DRAP drug manufacturing licence?
Obtain DRAP site suitability/verification: Drug Manufacturing Licence process begins with verification of proposed manufacturing premises and required checklist. Secure DRAP layout plan approval: Prepare compliant GMP manufacturing/testing facilities drawings, utilities and controlled production areas. Apply on Form 1 for DML and complete inspection: After site/layout stages, submit Form 1 with technical personnel, plant and quality documentation; undergo DRAP inspection and Central Licensing Board scrutiny. Register specific drug products separately: A facility DML is distinct from product registration, including Form 5-F and other applicable marketing authorisation.
This guide is general information, not advice on your facts. Check the applicable law, notifications, updated regulator checklists and jurisdiction before acting. The authority alone determines eligibility, acceptance and approval; no outcome or processing period is guaranteed.