0.812.101.951.41
Complementary agreement of 6 May 2015
The exchange of notes of 11 December 2001 concerning the validity of the Swiss legislation on therapeutic products in Liechtenstein concerning the marketing authorisation of medicinal products containing new active substances
Entered into force on 1 Er June 2015
(State 1 Er June 2015)
Translation 1
| Embassy of the Principality of Liechtenstein |
Bern, 6 May 2015 |
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Federal Department of Foreign Affairs |
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Bern |
The Embassy of the Principality of Liechtenstein presents its compliments to the Federal Department of Foreign Affairs and has the honour to acknowledge receipt of its note of 6 May 2015, which reads as follows:
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" The Federal Department of Foreign Affairs presents its compliments to the Embassy of the Principality of Liechtenstein and has the honour to submit the following case:
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With a view to the decision of the Court of Justice of the European Communities of 21 April 2005 in Joint Cases C-207/03 and C-252/03 and the resulting consequences for the Suisse-Liechtenstein Economic Area, the Federal Council Proposes-in accordance with the interviews conducted in this context as well as the experience acquired on the basis of the Complementary Agreement of 22 April 2005 2 Exchange of notes of December 11, 2001 3 , renewed on 23 May 2006 4 , 25 May 2009 5 And May 21, 2012 6 , between Switzerland and Liechtenstein concerning the validity of the Swiss legislation on medicinal products in Liechtenstein concerning the marketing authorisation of medicinal products containing new active substances-at Government of the Principality of Liechtenstein, on the basis of the legislation on therapeutic products applicable under the Treaty of 29 March 1923 between Switzerland and the Principality of Liechtenstein concerning the meeting of the Principality of Liechtenstein Liechtenstein to the Swiss customs territory (Customs Treaty) 7 , an exception regulation relating to the marketing authorisation of medicinal products containing new active substances.
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The exchange of notes of 11 December 2001 between Switzerland and the Principality of Liechtenstein concerning the validity of the Swiss legislation on therapeutic products in Liechtenstein is completed as follows:
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Authorizations to market medicinal products containing new active substances (New Chemical Entities, NCE or New Active Substances, NAS) issued by the Swiss Institute for Therapeutic Products on the basis of Art. 9 of the Swiss Federal Act of 15 December 2000 on medicinal products and medical devices 8 (Therapeutic Products Act, LPTh) are not automatically recognized in Liechtenstein.
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The Swiss Institute of Therapeutic Products immediately informs the Liechtenstein Office of the health of any new drug with NCE or NAS authorized in Switzerland. The Liechtenstein Office of Health establishes a list in which medicinal products whose marketing authorisation is not recognised in Liechtenstein are included. The list is updated regularly and published by the Liechtenstein Office of Health. For medicinal products on this list, the marketing authorisation is recognised in Liechtenstein after 12 months. Earlier recognition or also, in exceptional cases, subsequent recognition is possible.
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The Liechtenstein Office of Health may grant special authorisations for medicinal products intended for the treatment of a given patient, whose marketing authorisation issued by the Swiss Institute for Therapeutic Products does not Still recognised in Liechtenstein.
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The validity of this Agreement shall be limited to five years from its entry into force. Before the expiration of the time limit, the Contracting Parties shall consider all necessary amendments to this Regulation for further application. They shall enter into negotiations in good time on the basis of this Agreement.
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In the event that the Government of the Principality of Liechtenstein accepts the above, the present note and the Liechtenstein note-reply shall create an Agreement between the two Governments, which shall enter into force on 1 Er June 2015.
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The Federal Department of Foreign Affairs takes this opportunity to renew to the Embassy of the Principality of Liechtenstein the assurance of its high regard."
The Embassy of the Principality of Liechtenstein has the honour to inform the Federal Department of Foreign Affairs of the approval by the Government of Liechtenstein of the above. The Department's note and the Embassy's response form an agreement between the two governments. The latter shall enter into force on 1 Er June 2015.
The Embassy of the Principality of Liechtenstein takes this opportunity to renew to the Federal Department of Foreign Affairs the assurance of its high regard.
