Pakistan Licence-Holding Structure and Separate Registration

1. Key takeaways

GRZAN’s recommendation for the licence-holding structure of Pakistan projects is as follows: an independent licence-holding party — one that does not participate in channel distribution and holds a valid import institutional licence — holds the enlistment / registration certificate, and distributors sign separate distribution agreements. The rationale is rule-based rather than stylistic: Rule 14(1)(b) determines that the applicant can only be an importer holding an institutional licence, so the licence holder is by nature simultaneously the importer and the pharmacovigilance obligor; detaching the distribution channel from that role means the registration certificate does not need to move when distributors are changed. In other words, the structure exploits what the rules already require rather than inventing an arrangement the rules would have to tolerate. The certificate stays with a stable, dedicated entity whose business is holding and servicing the registration, while commercial partners come and go around it. For any manufacturer that expects to change distributors at least once during a five-year certificate life — which is most manufacturers — this separation is the single highest-value structural decision available at project start. It is also cheap at the start and expensive to retrofit: once a combined licence-holder-distributor holds the certificate, untangling the roles requires that party’s cooperation, which is exactly what a dispute removes.

2. Legal basis

The provisions supporting the structure are set out below: the applicant qualification rule that forces an importer into the role, the two application channels, the certificate and validity provisions, the labelling duty, the pharmacovigilance allocation, and the online channel through which applications now run.

3. Expert insights

Insight one: the structure solves the hostage problem. When the licence holder and the distributor are the same company, the registration certificate becomes that company’s bargaining chip in commercial negotiations. Once the roles are separated, the distributor holds only the right to sell and not the qualification for market access, and the negotiating position returns to normal. The asymmetry matters most at the worst possible moment: a dispute over volumes, pricing or credit typically coincides with a renewal window or a shipment at the port, and a combined licence-holder-distributor can time its leverage accordingly. Separation does not eliminate commercial disputes, but it removes the regulatory hostage from the negotiating table, which changes the tone of every subsequent discussion. It also clarifies who answers DRAP: questions about the certificate go to the holder, questions about the market go to the distributor, and neither can use the other as a shield.

Insight two: the independent licence holder must be capable of performing, not merely nominal. It must be able to import, to fulfil pharmacovigilance reporting, and to cooperate with market patrols. Article 33 of this series has already explained that the authorisation letter is the pivotal document of this structure; the supplement here is that the authorisation letter should also cover the custody and the handover of the technical documentation. A licence holder that exists only on paper cannot answer an inspector, cannot submit an adverse event report, and cannot defend the certificate when the authority asks questions. Selecting the holder is therefore a due-diligence exercise on capability, staffing and systems — not a search for the cheapest willing signatory. The custody point deserves emphasis as well: technical documentation scattered between the manufacturer and several local parties tends to be incomplete exactly when a deficiency response needs it, so naming a custodian with a defined archive is part of the structure, not an afterthought.

Insight three: three contract clauses cannot be omitted. Who keeps the original registration certificate; who initiates the renewal; and how cooperation for certificate transfer works when the cooperation ends — these three clauses determine whether the structure is actually workable. Everything else in the agreements can be negotiated flexibly; these three define the mechanics of exit and continuity, and they are precisely the clauses that are hardest to agree after a dispute has begun. A fourth point, though not a clause of its own, follows from them: the transfer process should be rehearsed on paper at signing, so that both parties know the sequence of handovers before anyone is emotionally invested in withholding one.

4. Practical recommendations

The three-document set that GRZAN implements for clients on Pakistan licence-holding structures consists of: a manufacturer authorisation letter — with a term covering the five-year registration validity, covering the enlistment / registration application and the holding of the certificate, and stipulating a notice period for termination and cooperation in transferring the certificate — plus a licence-holding service agreement covering vigilance, document custody, renewal and cooperation with inspections, plus a distribution agreement covering territory, volumes, pricing and termination clauses. The three documents reference one another, and only when their clauses do not conflict is the structure stable. The set should be drafted together, in a single pass, precisely because the interfaces between them — who notifies whom, who pays what, who hands over which document — are where conflicts hide. Drafted separately by different advisers at different times, the documents tend to duplicate each other on some points and contradict each other on the points that matter most.

5. Verification checklist

• □ The licence-holding party holds a valid import institutional licence (Form-2)
• □ The authorisation letter term covers the five-year registration validity
• □ Custody of the original certificate and cooperation in transferring it have been agreed
• □ The division of responsibility for vigilance, renewal and cooperation with inspections has been agreed
• □ The distribution agreement and the licence-holding agreement contain no conflicting clauses

Regulatory information verified as of October 28, 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