LICENSING AND REGISTRATIONS OF DRUG PRODUCTS

LICENSING AND REGISTRATIONS OF IMPORTED DRUG PRODUCTS

Only holder of valid Drug Sales License as Distributor can apply for registration of imported drug product. Registration process of imported drug product can be completed in below two steps.

STEP 1 DRUG SALES LICENSE AS DISTRIBUTOR

PMD provides comprehensive consultancy services to guide you through each step from correct selection of premises to installations, documentation and training of staff for successful inspection and licensing.

Company Registration

Company Registration as sole proprietor or partnership firm or Pvt Ltd.

Services Offered

NTN Registration
Sole Proprietor Company Registration
Partnership Firm Registration
Pvt Ltd Company Registration
Sales Tax Registration

Premises & Personnel

Premises with at least 400SFT covered area.

Storage facility containing

Refrigerator
Air conditioner
Environment Monitoring Devices
Racking facility for storage of drug products
Fire and safety devices

Hiring of Pharmacist as Qualified Person

Application

Service Offered

Preparation and submission of licensing application in competent provincial licensing authority

Inspection and Licensing

After successful scrutiny of application provincial drug inspectors conduct inspection of premises and system in place for safe distribution of drug products. Drug Sales License is granted after successful inspection.

PMD Consultancy provides technical support to answer queries by competent provincial licensing authority until issuance of Drug Sales License.

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STEP 2 IMPORTED DRUG PRODUCR REGISTRATION

Our services include:

Communication of exact documentation requirements to foreign manufacturer
Review of soft copies of documents before asking foreign manufacturers to go ahead with attestation/legalizations
Compilation of registrations dossiers followed by submission in DRAP Islamabad.

PMD Consultancy provides technical support to answer queries by competent Drug Regulatory Authority of Pakistan until issuance of Drug Products Registration Certificate

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LICENSING AND REGISTRATIONS OF LOCALLY MANUFACTURED DRUG PRODUCTS

Only holder of valid Drug Manufacturing License (DML) can apply for registration of locally manufactured drug product. DML holder can also apply for drug product to be manufactured via toll manufacturing through another DML holder. DRAP does not entertain any application from franchisers not having valid DML.

Below are steps for licensing and registration of locally manufactured drug products.

STEP 1 DRUG MANUFACTURING LICENSE

Company Registration

Services Offered

NTN Registration
Sole Proprietor Company Registration
Partnership Firm Registration
Pvt Ltd Company Registration
Sales Tax Registration

Site Approval

Not all sites are suited/approved by DRAP to establish a pharmaceutical manufacturing unit. Seeking PMD expert advise will help you save money and precious time.

Service Offered

Site survey and expert advise on suitability to setup pharmaceutical unit
DRAP Site Approval Application process

Layouts Approval

Services Offered

Layouts Development
DRAP Regulatory Submission and approvals

Civil Work as per approved layouts

PMD provides complete solution through its sister concern Megacon

Megacon offers below mentioned services

Working Plans Development
Structural Drawings
Civil Work Execution
Electric Load Calculation

CQV Services

Services Offered

PMD Consultancy Services provides complete technical support so that you get full value of your investments when it comes to procurements of HVAC, Plant Machinery and Quality Control Test Instruments.
Our subject matter experts compare and validate contractors offers, job execution and documentation against quality standards to pass cGMP and DRAP inspection requirements.

Drug Manufacturing License Application Process

Services Offered

Regulatory Submissions and follow up
Technical support related to Inspection and Licensing

PMD Consultancy provides complete support to answer queries by competent Drug Regulatory Authority of Pakistan until issuance of DML.

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STEP 2 DRUG PRODUCT REGISTRATION

Services Offered

Trials Manufacturing and Stability Studies Reports
CTD Dossiers Compilation
Drug Product Registration Application Process
PMD Consultancy provides complete support to answer queries by Drug Regulatory Authority of Pakistan until issuance of Drug Product Registration Certificate

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