DRUG & COSMETIC LICENCE — LICENCES & COMPLIANCE

Identify the right licensing route before you begin.

Review your proposed products, activity and premises to organise the application requirements relevant to drug or cosmetic operations.
  • Correct activity scope
  • Premises readiness
  • Organised technical records

Activity scope

Define what your business will do.

Premises data

Gather facility and site records.

Review my licensing requirements.

Tell us your proposed activity, location and current stage. We’ll help identify the documents and next steps.
Pharmaceutical and cosmetic compliance staff checking stock and records

UNDERSTAND YOUR REQUIREMENTS

The product and activity determine the route.

Drug and cosmetic requirements differ across manufacturing, sale, distribution and import activities. Product classification, premises and the competent authority need to be identified before a reliable checklist can be prepared. We help organise this initial review and the agreed application records, with technical and professional requirements assessed for the particular case.

PLAN THE RIGHT SUPPORT

Start with the work your business needs.

Drug sale or distribution review

Identify the intended retail or wholesale activity and relevant state requirements.

Manufacturing-route preparation

Review product, premises and technical-document needs for the proposed operation.

Cosmetic activity assessment

Distinguish manufacturing from import and identify the appropriate authority.

Existing-licence record review

Check the available licence, approved scope and proposed changes.

A clearer path from planning to paperwork.

Correct activity scope

Describe exactly what the business proposes to do.

Premises readiness

Identify the evidence and facility information relevant to review.

Organised technical records

Plan the product and personnel information the route may require.

Clear authority mapping

Separate state and central processes where applicable.

Check the proposed setup before you begin.

The correct route depends on the people, activity and location involved.

Product classification

Confirm whether the proposed products fall within the relevant regulatory category.

Activity and authority

Identify manufacturing, sale, distribution or import as applicable.

Premises and personnel

Review the facility and technical-personnel requirements for the specific route.

The final requirements depend on the applicable jurisdiction, current rules and the details of your case.

Who this service is designed for.

Choose the structure around your ownership and operating plans.

  • Businesses planning regulated drug sale or distribution
  • Manufacturers preparing a licensing discussion
  • Cosmetic businesses assessing manufacturing or import requirements

Prepare these details for your first review.

  • Business constitution and applicant particulars
  • Product list and proposed activity description
  • Premises ownership or lease and layout information
  • Technical-personnel qualifications and appointment records as applicable
  • Facility, storage and quality-system information required for the route
  • Existing licences and proposed changes where applicable

This is a starting checklist. Final requirements depend on your profile and the relevant filing procedure. Do not submit identity documents through the general enquiry form.

Understand each step before proceeding.

01

Classify the proposal

Confirm products, activity, location and intended scope.

Stage 1

02

Review readiness

Identify premises, personnel and technical-document requirements.

Stage 2

03

Prepare the application record

Organise the appropriate forms and supporting materials.

Stage 3

04

Follow official review

Address queries and any inspection requirements within the agreed scope.

Stage 4

Approval and processing remain subject to the applicable authority. Fixed completion dates are not guaranteed.

What affects the overall timeline?

Readiness assessment:

Premises and technical gaps can affect preparation time.

Official review:

The applicable authority’s scrutiny and inspection affect completion.

Ongoing conditions:

Operate only within the approved scope and applicable licence conditions.

UNDERSTAND THE DIFFERENCE

Manufacturing, sale and import need separate assessments.

ActivityPreparation focusWhat to establish
Manufacturing

Products, facility and technical controls.

The competent authority and applicable manufacturing route.

Sale or distribution

Premises, product scope and personnel requirements.

The licence category relevant to the business model.

Import

Products, manufacturer and importer particulars.

The relevant central registration or permission requirements.

One licence should not be assumed to cover every product, activity or premises. No operation should begin merely because an application has been submitted.

WHY TRADE INNOVATION

Clear preparation for your next business step.

Start with your plans and available records. We’ll help organise the work into an understandable scope.

A relevant checklist

Identify the documents needed for the agreed route.

Defined responsibilities

Know what information and decisions are needed from you.

Transparent next steps

Separate initial setup from continuing compliance and other licences.

Pharmaceutical and cosmetic compliance staff checking stock and records

CLIENT EXPERIENCES

EXPLORE OTHER BUSINESS OPTIONS

Compare the next steps for your business.

Questions about drug & cosmetic licence.

Clarify the scope before choosing the next step.
Is there one combined licence for every drug and cosmetic activity?

No. Product category, activity and premises determine the requirements and competent authority.

Are cosmetic manufacturing and import handled identically?

No. CDSCO describes state licensing for cosmetic manufacturing and central registration for cosmetic import. The particular product and activity need review.

Can an application replace an approval?

No. Submission does not itself authorise the proposed regulated operation.

Will technical staff or premises checks be required?

They may be required for the selected route. Identify these conditions before committing to the application.

Does the service guarantee licence approval?

No. The competent authority determines compliance and may require clarification, changes or inspection.

Review my licensing requirements.

Share your activity, location and current stage to begin the discussion.