Pakistan: Independent Licence Holder with a Separate Distribution Channel

1. Key takeaways

An independent licence holder (Independent License Holder) means a licensed importing entity that takes no part in channel distribution and is responsible only for holding the enlistment or registration certificate and performing the statutory duties of a certificate holder. In Pakistan this role is a valid one — Rule 14(1)(b) requires only that the applicant be “an importer (in his capacity as authorised representative) holding a valid establishment licence”, and does not require the applicant to be a distributor as well. Its commercial value lies in one sentence: when the distribution channel changes, the certificate stays put.

For an imported brand, this separation converts the registration certificate from a hostage of the commercial relationship into a stable asset of the market-entry project. Distributors can be appointed, replaced, or layered without touching the regulatory file, and the certificate’s five-year life is spent building product history rather than rebuilding it after every channel reshuffle. The cost of that stability is a genuine compliance workload carried by the independent holder, which is why the choice of holder and the drafting of the authorisation documents deserve the same rigour as the dossier itself. In practice, the structure works best when the manufacturer treats the holder as a regulatory partner with its own obligations, rather than as a passive repository for the certificate. That working posture also builds the trust that a long five-year cooperation needs.

2. Legal basis

The table below lists the provisions relevant to the independent licence holder structure, from applicant eligibility through labelling obligations to vigilance duties.

Two provisions carry particular weight for this structure. Rule 14(1)(b) confirms that a non-distributing importer may apply, and Rule 24(b) makes the local representative’s details a mandatory label element, which visibly anchors the independent holder to every unit placed on the market. The five-year validity under Rule 15(4) completes the picture: the structure is designed to be stable across the full life of each certificate.

3. Expert insights

Insight 1: the independence of an independent licence holder carries a legal cost. This is not a nominal appointment. The licence holder must carry out vigilance collection and reporting, cooperate with market surveillance, and keep the technical documentation — all of which are statutory obligations placed on the registration holder by the Pharmacovigilance Rules, 2022. Choosing a holder who is willing to lend a name but unwilling to bear responsibility is planting a problem in your own field. When an adverse event or a field safety corrective action arises, the regulator will expect the holder to act within defined timelines, and a holder without the systems to do so exposes the whole product line, not just itself. Manufacturers should therefore audit the holder’s vigilance arrangements — complaint intake, escalation paths, record keeping — before appointment and at reasonable intervals afterwards.

Insight 2: the letter of authorisation (LoA) is the pivot document of this structure. Through the letter of authorisation the manufacturer grants the licence holder the authority “to apply for and hold the enlistment or registration in Pakistan”. The scope of the LoA, its term, whether it can be sub-delegated, and how it is handled on termination directly determine whether this structure holds up. A narrowly drafted LoA may leave gaps that surface only at renewal; an over-broad one may create rights the manufacturer never intended to grant. The LoA should therefore be negotiated with the same seriousness as the distribution agreement, even though it is usually the shorter of the two documents. Where several products are covered, a schedule listing each certificate covered by the LoA avoids disputes about scope later.

Insight 3: Rule 24(b) puts the licence holder “on the product itself”. The label must carry the local representative’s information. This means the licence holder’s name travels with every unit to the end user, and once a quality problem appears, it is the first entity to be traced. This also explains why licence holders are applying increasingly strict review to the manufacturer’s product quality documentation before accepting an appointment: their own regulatory standing is now attached to someone else’s product. For the manufacturer, the practical read-across is straightforward: expect and welcome document scrutiny from the holder, because every gap the holder identifies before signature is a gap that will not become a regulatory finding later.

4. Practical recommendations

When GRZAN reviews contracts of this kind, it watches four clauses: the LoA term (recommended to be no shorter than the certificate’s 5-year validity), the termination notice period (recommended to be no less than 90 days), the cooperation obligations after termination (certificate transfer and handover of technical documentation), and the boundary of the licence holder’s exemption (the manufacturer’s warranty of product compliance). On Pakistan projects we have seen too many cases of “an LoA of one page with nothing written in it”, where the first channel change severed the certificate. In each of those cases the subsequent fix cost far more than the drafting would have: the replacement holder had to file afresh, and sales stopped for the interim. Spending the effort to get these four clauses right at signature is the cheapest insurance available in this market, and it protects both the product’s regulatory standing and the manufacturer’s freedom to change channels.

5. Verification checklist

• □ Independent licence holder holds a valid import establishment licence
• □ LoA clearly states the scope and term of the authorisation (covering the 5-year registration validity)
• □ Termination notice period and post-termination transfer cooperation obligations agreed
• □ Division of vigilance information collection and reporting agreed
• □ Label artwork reflects the licence holder’s name and address (Rule 24(b))

Regulatory information verified as of 28 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Pakistan. Our team prepares dossiers to DRAP expectations, manages eCTD-format submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com