ENLISTMENT OF HEALTH & OTC (NUTRACEUTICAL, HERBAL, UNANI) PRODUCTS

ENLISTMENT OF IMPORTED HEALTH AND OTC PRODUCTS (NUTRACEUTICALS) (FORM-7) AND MANUFACTURERS (FORM-6)

Only holder of valid Drug Sales License as Distributor can apply for enlistment of imported Health & OTC products (Nutraceuticals). Enlistment process of imported Health & OTC products (Nutraceuticals) can be completed in below three 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 ENLISTMENT OF FOREIGN MANUFACTURER AND IMPORTER (FORM-6)

PMD Consultancy services provides complete solution for Enlistment of Foreign Manufacturer of Health & OTC (Nutraceutical) Products.

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 Enlistment Application followed by submission in DRAP Islamabad.
Comprehensive technical support for successful inspection preparations
Good Distribution Practices documentation and training of staff on standard operating procedure and records.
PMD Consultancy provides complete support to answer queries by competent Drug Regulatory Authority of Pakistan until issuance of Form-6.

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STEP 3 ENLISTMENT OF IMPORTED HEALTH AND OTC PRODUCTS (NUTRACEUTICALS) (Form-7)

PMD Consultancy services provides complete solution for Enlistment of imported Health & OTC products (Nutraceuticals).

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 enlistment dossiers followed by submission in DRAP Islamabad.
PMD Consultancy provides complete support to answer queries by competent Drug Regulatory Authority of Pakistan until issuance of Form-7.

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ENLISTMENT OF LOCALLY MANUFACTURED HEALTH & OTC PRODUCTS (NUTRACEUTICALS)

Only holder of valid Form-6 can apply for enlistment of locally manufactured Health & OTC products (Nutraceuticals) in Pakistan. DML holder can also apply for enlistment of Health & OTC products (Nutraceuticals) to be manufactured via toll manufacturing through another DML holder. DRAP does not entertain any application from franchisers not having valid DML or Form-6.

Below are steps for licensing and registration of locally manufactured Health & OTC products (Nutraceuticals).

Step 1 ENLISTMENT MANUFACTURER OF HEALTH & OTC PRODUCTS (NUTRACEUTICALS) (FORM-6)

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 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 Health & OTC (Nutraceuticals) manufacturing 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.

Form-6 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 Form-6

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Step 2 ENLISTMENT OF LOCALLY MANUFACTURED HEALTH & OTC PRODUCTS (NUTRACEUTICALS) FORM-7

Services Offered

Trials Manufacturing and Stability Studies Reports
Dossiers Compilation
Enlistments Application Process
PMD Consultancy provides complete support to answer queries by competent Drug Regulatory Authority of Pakistan until issuance of Form-7

CONSULT NOW