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Document C2006/326/84
Case C-452/06: Reference for a preliminary ruling from the High Court of Justice (England and Wales), Queen's Bench Division (Administrative Court) (United Kingdom) made on 9 November 2006 — The Queen on the application of Synthon BV v Licensing Authority, Interested Party: Smithkline Beecham plc
Case C-452/06: Reference for a preliminary ruling from the High Court of Justice (England and Wales), Queen's Bench Division (Administrative Court) (United Kingdom) made on 9 November 2006 — The Queen on the application of Synthon BV v Licensing Authority, Interested Party: Smithkline Beecham plc
Case C-452/06: Reference for a preliminary ruling from the High Court of Justice (England and Wales), Queen's Bench Division (Administrative Court) (United Kingdom) made on 9 November 2006 — The Queen on the application of Synthon BV v Licensing Authority, Interested Party: Smithkline Beecham plc
OJ C 326, 30.12.2006, p. 40–41
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
30.12.2006 |
EN |
Official Journal of the European Union |
C 326/40 |
Reference for a preliminary ruling from the High Court of Justice (England and Wales), Queen's Bench Division (Administrative Court) (United Kingdom) made on 9 November 2006 — The Queen on the application of Synthon BV v Licensing Authority, Interested Party: Smithkline Beecham plc
(Case C-452/06)
(2006/C 326/84)
Language of the case: English
Referring court
High Court of Justice (England & Wales), Queen's Bench Division (Administrative Court)
Parties to the main proceedings
Applicant: Synthon BV
Defendant: Licensing Authority
Interested Party: Smithkline Beecham plc
Questions referred
1. |
Where:
|
2. |
If the answer to question 1(a) is no and the answer to question 1(b) is yes, where the concerned Member State rejects the application at the validation stage on the grounds that the Product is not essentially similar to the Reference Product, and thereby fails to recognise the marketing authorisation granted by the reference Member State or to invoke the procedure set out in Articles 29 to 34 of the Directive, does the failure by the concerned Member State to recognise the marketing authorisation granted by the reference Member State in the circumstances referred to above amount to a sufficiently serious breach of Community law within the meaning of the second condition in the judgment in Joined Cases C-46/93 and C-48/93 Brasserie du Pecheur and Factortame. Alternatively, what factors ought the national court to take into consideration when it comes to determine whether such failure amounts to a sufficiently serious breach? |
3. |
Where the failure of the concerned Member State to recognise the marketing authorisation granted by the reference Member State as set out in question 1 above is based on a general policy adopted by the concerned Member State that different salts of the same active moiety cannot, as a matter of law, be considered essentially similar, does the failure by the concerned Member State to recognise the marketing authorisation granted by the reference Member State in the circumstances referred to above amount to a sufficiently serious breach of Community law within the meaning of the second condition in the judgment in Joined Cases C-46/93 and C-48/93 Brasserie du Pecheur and Factortame. Alternatively what factors ought the national court to take into consideration when it comes to determine whether such failure amounts to a sufficiently serious breach? |
(1) OJ L 311, p. 67