The Importer Licence to Operate

Nothing reaches a Philippine shelf without two permissions, and they come in a fixed order. An exporter who understands only the second one will spend months waiting on the first without knowing it.

The rules changed in November 2024

Administrative Order 2024-0015, dated 22 November 2024, prescribes the rules, requirements and procedures for applying for a Licence to Operate. Its repealing clause is explicit: Administrative Order 2020-0017, the order most guidance on this market still cites, is repealed, except for the purposes of two transitional paragraphs.

An earlier version of this page rested on 2020-0017 as live law. It is not, and if your importer or an adviser is working from it, the validity periods below are the first thing to check.

The order takes effect fifteen days after publication in the Official Gazette or a newspaper of general circulation and upon filing with the University of the Philippines Office of the National Administrative Register. Applications already in the system before that date continue to be processed under 2020-0017 until exhausted.

It is your importer's licence, and it now lasts much longer

A Canadian exporter with no Philippine establishment does not hold a Licence to Operate and cannot. Whoever you appoint holds it, which makes it an asset of theirs that your market access depends on.

The validity periods under the new order are substantial. For micro and small enterprises, an initial licence runs three years and a renewal six. For medium and large enterprises, an initial licence runs six years and a renewal twelve.

That cuts both ways. A long licence means less administrative churn, and it also means a buyer's licence may have been issued years ago under a different scope. Ask what it actually covers and when it expires, not merely whether they have one.

The renewal cliff

An application for renewal, automatic or regular, is filed through the eServices Portal System within ninety calendar days before the licence expires. Where a timely and sufficient renewal application has been made for an activity of a continuing nature, the existing licence does not expire until the FDA decides on the application.

Miss the date and the licence attracts a surcharge under the implementing rules of Republic Act 9711 and FDA Circular 2011-004. Miss it by a hundred and twenty days from expiry and the order allows the licence to be suspended, cancelled or revoked automatically, without notice and hearing, with the establishment given six working days from receipt of the order to show cause why it should not stand. A suspension itself may not exceed one year.

For a Canadian supplier this is a counterparty risk that has nothing to do with your product. If your importer's licence lapses, your registrations sit behind it.

Pre-licensing inspection is being extended

Pre-licensing inspection is maintained for all health product manufacturers and required for pharmaceutical establishments from the order's effectivity. Within five years of the order coming into force it will be required for other health product establishments as well, and the FDA may bring that forward by notice.

There are transitional periods elsewhere in the order: one year for the variation covering the list of sources, authorised suppliers and clients for non-pharmaceutical health products, and two years for certain other establishment types.

What to ask before you appoint anybody

Four questions, in this order. Does the candidate hold a current Licence to Operate, and what scope of activity does it cover. When does it expire, and under which order was it issued. Have they filed renewals on time historically. And who, in your agreement, bears the cost if the licence lapses while your product is in the market.

The product registration that sits on top of this licence is covered on its own page, and the two cannot be separated: the registration is filed against the licence and, under the current fee order, cannot outlive it.