# C_2006326EN.01004001.xml

| 30.12.2006 | EN | Official Journal of the European Union | C 326/40 |
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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:
—
a Member State (‘the concerned Member State’) receives an application pursuant to Article 28 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use( 1 ) (‘the Directive’) for mutual recognition, in the concerned Member State of a marketing authorisation of a medicinal product (‘the Product’) granted by another Member State (‘the reference Member State’); —
such marketing authorisation was granted by the reference Member State pursuant to the abridged application procedure in Article 10(1)(a)(iii) of the Directive on the grounds that the Product is essentially similar to another medicinal product which has already been authorised within the EU for the requisite period (‘the Reference Product’); —
the concerned Member State operates a procedure for validation of the application during which it checks that the application contains the particulars and documents required by Articles 8, 10(1)(a)(iii) and 28 of the Directive, including that the particulars provided are compatible with the legal basis upon which the application is submitted;
(a)
is it compatible with the Directive and in particular Article 28 for the concerned Member State to check that the Product is essentially similar to the Reference Product (without carrying out any substantive assessment), to refuse to accept and review the application and not proceed to recognise the marketing authorisation granted by the reference Member State on the grounds that in its opinion the Product is not essentially similar to the Reference Product? or (b)
is the concerned Member State obliged to recognise the marketing authorisation granted by the reference Member State within 90 days of receipt of the application and the assessment report pursuant to Article 28(4) of the Directive unless the concerned Member State invokes the procedure set out in Articles 29 to 34 of the Directive (which is applicable where there are grounds for supposing that the marketing authorisation of the Product may present a risk to public health within the meaning of Article 29 of the Directive). | — | a Member State (‘the concerned Member State’) receives an application pursuant to Article 28 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use( 1 ) (‘the Directive’) for mutual recognition, in the concerned Member State of a marketing authorisation of a medicinal product (‘the Product’) granted by another Member State (‘the reference Member State’); | — | such marketing authorisation was granted by the reference Member State pursuant to the abridged application procedure in Article 10(1)(a)(iii) of the Directive on the grounds that the Product is essentially similar to another medicinal product which has already been authorised within the EU for the requisite period (‘the Reference Product’); | — | the concerned Member State operates a procedure for validation of the application during which it checks that the application contains the particulars and documents required by Articles 8, 10(1)(a)(iii) and 28 of the Directive, including that the particulars provided are compatible with the legal basis upon which the application is submitted;
(a)
is it compatible with the Directive and in particular Article 28 for the concerned Member State to check that the Product is essentially similar to the Reference Product (without carrying out any substantive assessment), to refuse to accept and review the application and not proceed to recognise the marketing authorisation granted by the reference Member State on the grounds that in its opinion the Product is not essentially similar to the Reference Product? or (b)
is the concerned Member State obliged to recognise the marketing authorisation granted by the reference Member State within 90 days of receipt of the application and the assessment report pursuant to Article 28(4) of the Directive unless the concerned Member State invokes the procedure set out in Articles 29 to 34 of the Directive (which is applicable where there are grounds for supposing that the marketing authorisation of the Product may present a risk to public health within the meaning of Article 29 of the Directive). | (a) | is it compatible with the Directive and in particular Article 28 for the concerned Member State to check that the Product is essentially similar to the Reference Product (without carrying out any substantive assessment), to refuse to accept and review the application and not proceed to recognise the marketing authorisation granted by the reference Member State on the grounds that in its opinion the Product is not essentially similar to the Reference Product? or | (b) | is the concerned Member State obliged to recognise the marketing authorisation granted by the reference Member State within 90 days of receipt of the application and the assessment report pursuant to Article 28(4) of the Directive unless the concerned Member State invokes the procedure set out in Articles 29 to 34 of the Directive (which is applicable where there are grounds for supposing that the marketing authorisation of the Product may present a risk to public health within the meaning of Article 29 of the Directive). |
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| — | a Member State (‘the concerned Member State’) receives an application pursuant to Article 28 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use( 1 ) (‘the Directive’) for mutual recognition, in the concerned Member State of a marketing authorisation of a medicinal product (‘the Product’) granted by another Member State (‘the reference Member State’); | | | | | | | | | | |
| — | such marketing authorisation was granted by the reference Member State pursuant to the abridged application procedure in Article 10(1)(a)(iii) of the Directive on the grounds that the Product is essentially similar to another medicinal product which has already been authorised within the EU for the requisite period (‘the Reference Product’); | | | | | | | | | | |
| — | the concerned Member State operates a procedure for validation of the application during which it checks that the application contains the particulars and documents required by Articles 8, 10(1)(a)(iii) and 28 of the Directive, including that the particulars provided are compatible with the legal basis upon which the application is submitted;
(a)
is it compatible with the Directive and in particular Article 28 for the concerned Member State to check that the Product is essentially similar to the Reference Product (without carrying out any substantive assessment), to refuse to accept and review the application and not proceed to recognise the marketing authorisation granted by the reference Member State on the grounds that in its opinion the Product is not essentially similar to the Reference Product? or (b)
is the concerned Member State obliged to recognise the marketing authorisation granted by the reference Member State within 90 days of receipt of the application and the assessment report pursuant to Article 28(4) of the Directive unless the concerned Member State invokes the procedure set out in Articles 29 to 34 of the Directive (which is applicable where there are grounds for supposing that the marketing authorisation of the Product may present a risk to public health within the meaning of Article 29 of the Directive). | (a) | is it compatible with the Directive and in particular Article 28 for the concerned Member State to check that the Product is essentially similar to the Reference Product (without carrying out any substantive assessment), to refuse to accept and review the application and not proceed to recognise the marketing authorisation granted by the reference Member State on the grounds that in its opinion the Product is not essentially similar to the Reference Product? or | (b) | is the concerned Member State obliged to recognise the marketing authorisation granted by the reference Member State within 90 days of receipt of the application and the assessment report pursuant to Article 28(4) of the Directive unless the concerned Member State invokes the procedure set out in Articles 29 to 34 of the Directive (which is applicable where there are grounds for supposing that the marketing authorisation of the Product may present a risk to public health within the meaning of Article 29 of the Directive). | | | | | | |
| (a) | is it compatible with the Directive and in particular Article 28 for the concerned Member State to check that the Product is essentially similar to the Reference Product (without carrying out any substantive assessment), to refuse to accept and review the application and not proceed to recognise the marketing authorisation granted by the reference Member State on the grounds that in its opinion the Product is not essentially similar to the Reference Product? or | | | | | | | | | | |
| (b) | is the concerned Member State obliged to recognise the marketing authorisation granted by the reference Member State within 90 days of receipt of the application and the assessment report pursuant to Article 28(4) of the Directive unless the concerned Member State invokes the procedure set out in Articles 29 to 34 of the Directive (which is applicable where there are grounds for supposing that the marketing authorisation of the Product may present a risk to public health within the meaning of Article 29 of the Directive). | | | | | | | | | | |

| 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? |
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| 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? |
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( 1 )  OJ L 311, p. 67

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