UK parallel import licences: simple, standard and complex applications, what each needs, and the law behind them

A UK parallel import licence, the PLPI, lets a company bring in a medicine authorised in a country of the European Economic Area and sell it in the UK on the strength of a UK product that is already licensed. The importer does not repeat the originator’s trials. It shows that its product is, for practical purposes, the UK product, and the MHRA checks that claim.

How hard that check is depends on how closely the two products are related. That is what the three categories measure: simple, standard and complex. They are not three legal routes. There is one legal test, and the categories set how much work the MHRA does to apply it and how much the importer pays.

The one test

Since 31 December 2020 the test has been spelled out in UK law. Until then, regulation 48 of the Human Medicines Regulations 2012 simply defined a parallel import licence as one granted “in compliance with the rules of European Union Law relating to parallel imports”. The Brexit amendments replaced that with a self-standing definition. Regulation 48 now defines a parallel import licence as one that authorises its holder to place on the market a medicine imported from an EEA state where the product:

(a) has been granted an EU marketing authorisation or a marketing authorisation in an EEA State under the 2001 Directive; and (b) is essentially similar to a product that has been granted a UK marketing authorisation

“Essentially similar” then has a meaning of its own. The imported product must have been manufactured to the same formulation as the UK product, contain the same active ingredients and have the same therapeutic effect, and “any differences in a product’s formulation are to be ignored in so far as they are considered to be immaterial by the licensing authority”.

Two consequences follow from that wording. The source must be an EEA state, so the UK scheme takes in imports from the EU, Iceland, Liechtenstein and Norway and nothing else. And the reference must be a UK marketing authorisation, so there is no PLPI for a product with no UK counterpart. The scheme also runs one way: under the UK’s exhaustion rules goods can come in from the EEA, but UK goods cannot go the other way without the rights holder’s consent.

The three categories

The categories are defined in the fees rules, the Medicines (Products for Human Use) (Fees) Regulations 2016, and repeated in the MHRA’s application guidance.

Category	When it applies	MHRA fee (April 2026)
Simple	The imported product and the UK product share a common origin	£2,400
Standard	No common origin, and none of the complex features below	£10,617
Complex	No common origin, and at least one of the complex features	£24,343

Simple: a common origin

A common origin means the two products come from the same source. The MHRA’s guidance puts it in terms of the two marketing authorisation holders: they are companies in the same group, or there is a licensing agreement between them. The fees rules put it slightly differently, in terms of the manufacturers and the product itself. The manufacturers must be the same company, belong to the same group, or be independent companies with agreements with the same licensor. And the two products must be made to the same formulation, with the same active ingredients and the same pharmaceutical form, with no difference that would change the therapeutic effect.

The second half matters. A common origin is not enough on its own. A group product reformulated for one market can still fall outside the simple category if the change is material.

Standard: no common origin

A standard application is for an imported product with no common origin with the UK product, for example where two unrelated companies sell the same molecule in different countries, but without any of the features on the complex list. The MHRA has to establish similarity without the shared dossier that a common origin implies.

Complex: no common origin, and a feature that needs a closer look

An application is complex where there is no common origin and the imported product has one of the features below. The MHRA’s guidance lists eight:

• a new excipient;
• an active ingredient made by a different route of synthesis from the UK product;
• a controlled-release preparation;
• a sterile product sterilised in a different way from the UK product;
• a sterile product whose container is made of a different material;
• an influenza vaccine;
• a metered-dose inhaler;
• a powder for inhalation.

The fees rules carry a longer list. They add an active ingredient that does not come from a manufacturer already named for it in a UK-authorised product, unless it is covered by a European Pharmacopoeia certificate of suitability. They also add products whose authorisation abroad rested on something other than the plain generic routes: a hybrid application, a dossier based on published literature, or new trial results. “New excipient” also has a precise meaning: an ingredient other than an active that has not been used before in a UK-authorised product given by the same route, with a narrower rule for oral products.

The list describes products where small differences can matter: how fast a tablet releases its drug, how an inhaler delivers its dose, how a sterile product stays sterile. The point is not that these products cannot be parallel imported. It is that the MHRA has to look harder before it can say the difference is immaterial.

One exclusion

The fees rules also say an application falls into none of the three categories where the applicant and the holder of the marketing authorisation in the exporting country are parent and subsidiary. For fee purposes it is not a parallel import application at all.

What every application needs

Whatever the category, the submission is the same. It goes through the MHRA portal, with:

• the electronic application form, naming the UK product the licence will cross-refer to;
• a cover letter;
• mock-ups of every piece of labelling, showing the overlabels, intact primary packs and braille;
• the patient information leaflet in English, following the UK product’s leaflet as closely as possible;
• evidence that the leaflet is readable, by a full user test, a bridging study or a showing that it matches the UK leaflet in style and format;
• the company functions list: the sites that assemble, release, store, import and distribute the product;
• a complete scan of an imported sample pack, sent separately;
• a signed declaration that the product will be bought only from authorised suppliers, unless a full supplier list is provided.

Behind the application sit the licences the importer must already hold: a wholesale dealer’s licence covering import, storage and sale, a manufacturer’s licence approved for repackaging parallel imports if the packs are opened or reboxed, and a Home Office import licence for controlled drugs.

The MHRA does not publish a different document list for standard or complex applications. What differs is the assessment, and the fee reflects it. In a standard or complex case the agency has to satisfy itself, from what it holds on the UK product and what it can obtain from the exporting country’s regulator, that the imported product is the same medicine in every way that matters.

After grant

• One request for information. The MHRA sends one request for anything missing. The applicant has 30 calendar days to answer it, and an incomplete answer means refusal.
• Five years. A PLPI lasts five years. The renewal must be filed in the three months before expiry and cannot be used to change the licence.
• Variations. When the UK reference product’s licence changes, the PLPI must be varied to match, and failing to do so is a breach of the licence. Some variations, such as a change of the UK cross-referred licence or, for centrally authorised products, a change of the EU authorisation holder or manufacturer, can be made by “tell and do”: the importer files and carries on repackaging while the MHRA assesses. A standard variation costs £479 and an administrative one is free.
• Trade marks. The MHRA does not consider trade marks when it grants a PLPI. The right to use the name and to repackage is a separate question, governed by the BMS v Paranova conditions and the 2022 repackaging rulings.

The legal basis

The PLPI scheme began as an administrative arrangement, built by the MHRA’s predecessor on rulings of the Court of Justice about the free movement of goods. Those rulings are where each category comes from.

De Peijper, 1976: no second dossier

The Court held that a country’s health authorities may not make a second importer resupply the pharmaceutical particulars they already hold. Where the imported product is the same as one already authorised, or its differences have no therapeutic effect, asking again does nothing for public health and simply blocks trade. This is the foundation of every parallel import scheme in Europe (case note). The Commission’s 1982 communication on parallel imports built on it, and the UK’s first parallel import notes followed in 1984.

Smith & Nephew and Primecrown, 1996: the simple category

Smith & Nephew sold Ditropan (oxybutynin) in the UK under a licence from Marion Merrell Dow, a US company. Primecrown obtained a UK licence to import Ditropan from Belgium, where Marion Merrell Dow’s own Belgian company sold it. The MCA then withdrew the licence, because it had wrongly assumed that Smith & Nephew and the Belgian company were in the same group, and the High Court asked the Court of Justice what the rule was.

The Court answered on 12 November 1996. Products made by independent companies under agreements with the same licensor have a common origin, just as group products do. If the two products, “although not identical in all respects, have at least been manufactured according to the same formulation and using the same active ingredient” and have the same therapeutic effects, the authority must treat the import as covered by the existing UK authorisation, unless there is a countervailing health concern. If they do not meet that test, the importer needs a full marketing authorisation. That ruling is the simple category, and its wording is the source of the “essentially similar” definition now in regulation 48 (case note).

Rhône-Poulenc Rorer, 1999: different excipients are not fatal

Rhône-Poulenc Rorer had replaced its UK sleeping tablet Zimovane (zopiclone) with a new version using different excipients and a different manufacturing process, and surrendered the UK licences for the old one, which it kept selling elsewhere in Europe. The MCA let parallel imports of the old version continue, attaching them to the new version’s licence, and the company challenged that.

The Court held on 16 December 1999 that the MCA was right to do so, provided it could verify that the imported version met the requirements on quality, efficacy and safety and could ensure normal pharmacovigilance. Different excipients can affect safety, the Court accepted, but that possibility “does not mean” a simplified procedure can never be used. The authority must authorise the import when it is satisfied the product “does not pose a problem for public health”. This is the principle behind the complex list: the listed features are reasons to look harder, not bars (case note).

Kohlpharma, 2004: common origin is not a condition

Kohlpharma wanted to import Jumex (selegiline) from Italy into Germany by reference to Movergan. Both were made from the same Hungarian active ingredient, but under different agreements, so there was no common origin, and the German authority refused for that reason alone.

The Court held on 1 April 2004 that this was not allowed. Where the safety and efficacy assessment for the authorised product can be used for the imported one “without any risk to public health”, the application cannot be rejected “solely on the ground that the two medicinal products do not have a common origin”. A common origin “may constitute an important element” in showing similarity, but its absence is not in itself a ground for refusal. The importer can make its case with the information available to it, and where it makes similarity at least plausible, the authority must decide on the fullest information possible, including what it can obtain from regulators in other member states.

This is the ruling that makes the standard and complex categories necessary. Without it, an application with no common origin could simply be refused (case note).

The reference licence and later changes

Two further lines of cases deal with what happens after grant. From Ferring in 2002 to Delfarma in 2021, the Court has held that a parallel import licence cannot simply die because its reference licence is withdrawn or lapses: the authority must look at the health consequences first. The Delfarma note and the sunset clause explainer cover that. And on 8 October 2020, in kohlpharma (C-602/19), the Court held that an authority may not refuse to update a parallel import licence’s particulars solely because the reference authorisation has expired, while the licence is still valid and there is no real evidence of a risk to health.

How the law stands in the UK now

Three sources now sit on top of one another.

• The statute. Regulation 48 of the Human Medicines Regulations, as substituted with effect from 31 December 2020, defines the licence and the “essentially similar” test in its own words, where it used to point to EU law.
• The fees rules. The 2016 Fees Regulations define the three categories. They still describe a parallel import licence as one granted “in compliance with the rules of European Union law relating to parallel imports”.
• The case law. Court of Justice rulings given before the end of 2020, including De Peijper, Smith & Nephew, Rhône-Poulenc Rorer, Kohlpharma, Ferring and kohlpharma, remain part of UK law as assimilated case law, which the Court of Appeal and the Supreme Court can depart from. Later rulings, including Delfarma in 2021, do not bind UK courts, although they may take them into account.

Where the rules leave room for argument

• What “common origin” means. The MHRA’s guidance defines it by the authorisation holders; the fees rules define it by the manufacturers and the licensor, and add a same-formulation condition. A case where the holders are related but the manufacturers are not, or the reverse, can be argued either way, and it is worth agreeing the category with the MHRA before filing.
• Category against outcome. The category sets the fee and the depth of the assessment. It does not decide the result. A complex application can succeed, and a simple one can fail if the formulation has changed materially.
• Evidence in a standard or complex case. Kohlpharma lets the importer rely on the information it can get and puts the burden of finding the rest on the authority. How far the MHRA goes in obtaining data from an exporting regulator after Brexit is not published.
• The reference licence. Neither regulation 48 nor the MHRA’s guidance says what happens to a PLPI when its UK reference licence lapses, for example under the sunset clause. The pre-2021 case law requires a look at the health consequences first, and the question is one to put to the MHRA case by case.

What it means if you are…

A parallel importer. Before you file, work out the category. A common origin means a quick simple application. Without one, check the product against the complex list, because a complex application costs ten times as much as a simple one and the assessment is longer. A standard application turns on showing, with what you can obtain, that the imported product is the UK product in every way that matters.

An originator or UK licence holder. You cannot stop a PLPI because your product and the imported one were made by different companies. Smith & Nephew does allow a licence holder to challenge a competitor’s authorisation in court where it should have been granted under the full procedure. Trade marks are a separate fight, which the MHRA does not decide.

A wholesaler or buyer. A PLPI pack is a UK-licensed medicine. It carries the importer’s licence number, a UK leaflet and “UK Only” on the pack since the Windsor Framework changes. When the licence of the UK product it cross-refers to changes, the PLPI has to change with it.

MPA Search lists UK parallel import licences, current and lapsed, so you can see which products are already imported and from where before you apply for, or buy against, a new one.