Rhône-Poulenc Rorer: a parallel import with different excipients can still use the simplified route

What was decided

May & Baker held UK marketing authorisations, granted in 1989 and 1993, for Zimovane, a zopiclone tablet for insomnia, and had appointed Rhône-Poulenc Rorer, a company in the same group, to make and sell it. After more than three years of research the group developed a new version with the same active ingredient and therapeutic effect but a different manufacturing process and different excipients, which it said gave a particular benefit to public health. The MCA approved it as a variation on 11 July 1996, and on 31 July 1996, at the company’s request, revoked the authorisations for the old version. The group stopped selling the old version in the UK but went on selling it in other member states.

Several companies held UK parallel import licences for the old version. Under paragraph 12 of the MCA’s parallel import notes, MAL 2 (PI), those licences lapsed when the UK authorisation they depended on was revoked. The MCA told the holders they could apply to vary their licences to a new reference product, and between November 1996 and May 1997 it decided to treat the licences as still valid, appended to the authorisation for the new version. From 1 August 1996 it also granted three new parallel import licences for the old version. Rhône-Poulenc Rorer and May & Baker sought judicial review, arguing that with no UK authorisation for the old version in force, imports of it were not parallel imports at all, and that Smith & Nephew’s “same formulation” condition covered excipients as well as actives. The High Court referred the question.

The Court of Justice began from De Peijper and Smith & Nephew: the full authorisation procedure cannot be imposed on parallel imports, but the simplified route must not relax safety requirements. It then took the three objections in turn. On formulation, the Court accepted that differences in excipients can affect safety, through shelf-life or bioavailability for instance, but held that this possibility “does not mean” that national authorities may never use simplified procedures where excipients differ. The authority must authorise the import where it is convinced the product poses no problem for public health, and must satisfy itself at the time of import, on the information it holds, that the product has the same active ingredient and therapeutic effect and raises no problem of quality, efficacy or safety. On pharmacovigilance, it is enough that the importing authority can obtain the data through cooperation with other member states where the old version is still authorised, and can compel the UK licence holder, as a member of the group that holds those authorisations, to supply what is needed. On the public-health benefit of the new version, even if real, it does not compel the authority to push parallel importers onto the full route when it considers the imported product safe in normal conditions of use.

The Court expressly left open whether a parallel import licence may lapse automatically when the holder of the reference authorisation surrenders it, because the MCA had kept the licences alive by attaching them to the new version. That question was answered in Delfarma in 2021.

Timeline

Date	Event
1989 and 1993	MCA grants May & Baker marketing authorisations for Zimovane tablets and capsules
11 July 1996	MCA approves variations introducing the new version of Zimovane
31 July 1996	At the group’s request, the MCA revokes the authorisations for the old version; the existing parallel import licences lapse under MAL 2 (PI) paragraph 12
1 August 1996	MCA grants three new parallel import licences for the old version
November 1996 to May 1997	MCA decides to treat the existing parallel import licences as valid, appended to the new version’s authorisation
14 February and 5 June 1997	Rhône-Poulenc Rorer and May & Baker apply for judicial review
31 July 1997	High Court refers two questions to the Court of Justice (received 1 April 1998)
16 December 1999	Judgment

What it means if you are…

A parallel trader. “Same formulation” in the Smith & Nephew test does not mean identical excipients. An imported version that differs in excipients and process from the UK product can still be licensed as a parallel import, if the regulator can satisfy itself on quality, efficacy and safety. In the UK that is what the “complex” application category exists for: the listed features, such as a new excipient or a different route of synthesis, are reasons for a closer look, not bars. The regulator can also keep your licence alive by attaching it to a successor reference product when the original is surrendered.

An originator. Reformulating a product in one market and withdrawing the old version there does not, by itself, close that market to parallel imports of the old version from countries where you still sell it. Nor does the argument that the reformulation is better for patients. If you want the old version off the market, the route is a health case the regulator accepts, not a licence surrender.

A wholesaler or buyer. A parallel-imported product may be an older version of the UK brand, with different excipients. The regulator has judged it safe and effective, but it is not necessarily identical to the UK pack; the patient leaflet and the licence will say what the differences are.

Status and what to watch

Good law. The ruling is the reason the UK’s complex application list is a list of features that need extra assessment rather than grounds for refusal, and the Court’s insistence that the importing authority “ensure normal pharmacovigilance” is the thread picked up in Ferring (2002), the Paranova cases (2003) and Delfarma (2021) on what happens when a reference authorisation goes. In the United Kingdom the judgment is assimilated case law, open to departure by the Court of Appeal and the Supreme Court; neither has departed from it. How the test fits with the current UK categories and fees is in the explainer.

This note is a summary for commercial readers and is not legal advice.