0.812.101.951.4

Exchange of notes of 11 December 2001 between Switzerland and Liechtenstein concerning the validity of the Swiss legislation on therapeutic products in Liechtenstein ¹

Entered into force on 1 ^Er January 2002

(State on 4 July 2006)

Translation ²

Federal Department
Foreign Affairs	Bern, 11 December 2001
	Embassy of the Principality of Liechtenstein
	Bern

The Federal Department of Foreign Affairs presents its compliments to the Embassy of the Principality of Liechtenstein and has the honour to acknowledge receipt of its note of 11 December 2001, which reads as follows:

" The Embassy of the Principality of Liechtenstein presents its compliments to the Federal Department of Foreign Affairs and has the honour to submit the following case:

In the light of art. 4, 7 and 10 of the Treaty of 29 March 1923 between Switzerland and the Principality of Liechtenstein concerning the meeting of the Principality of Liechtenstein to the Swiss customs territory ³ (Customs Treaty), having regard to the Agreement of 2 November 1994 between Switzerland and Liechtenstein ⁴ Concerning the said Treaty and in view of the fact that new legislation on therapeutic products enters into force 1 ^Er January 2002 in Switzerland, reflecting the Intercantonal Convention of 3 June 1971 on the control of medicinal products ⁵ And therefore the Liechtenstein participation in the Convention, the Government of the Principality of Liechtenstein proposes to the Swiss Federal Council, in reference to the discussions in this regard, that the Exchange of Notes of 27 February 1973 between the Switzerland and Liechtenstein concerning the validity of the Inter-cantonal Convention on the Control of Medicines for the Principality of Liechtenstein ⁶ , as well as the Exchange of Notes of 1 ^Er May 1995 between the Federal Department of Foreign Affairs and the Embassy of the Principality of Liechtenstein concerning the modification of the Exchange of Notes of 27 February 1973 ⁷ Be repealed and replaced by the following provisions:

1. Applicability of Swiss legislation on therapeutic products

The Swiss legislation on therapeutic products determining at the time of entry into force of this Agreement in the Principality of Liechtenstein and applicable subject to the provisions set out below under the Customs Treaty Annex to this Agreement. The Medicines and Medical Devices Act of December 15, 2000 (Therapeutic Products Act, LPTh) ⁸ Shall apply within the limits set out in the Annex. The examination of the limits of applicability and the definition of the applicability of the articles of other Swiss legislative acts mentioned as well as the applicability of the amendments of the LPTh take place in the framework of the due process The elimination of divergences concerning the annexes to the Customs Treaty. The Annex to this Agreement is transferred to Annex I to the said Treaty and is therefore an integral part thereof.

2. EEA law

The lawfulness of the trade in therapeutic products in the Principality of Liechtenstein under the law of the EEA is governed by the provisions of the Agreement of 2 November 1994 between Switzerland and Liechtenstein concerning the Customs Treaty.

3. Competences of the Liechtenstein authorities

3.1 Granting permissions

The Liechtenstein Drug Control Service has jurisdiction over the granting of authorisations within the meaning of Art. 5, para. 1, art. 18, para. 1 and art. 28, para. 1, LPTh. Authorizations are issued in agreement with Swissmedic, Swiss Institute for Therapeutic Products. Authorizations within the meaning of s. 34, para. 1 and 35, para. 1, LPTh falls within the competence of the Liechtenstein drug control service only to the extent that the products are exclusively intended for the Liechtenstein market. Authorisations granted by the Liechtenstein drug control service under the Swiss therapeutic products legislation are recognised by the Swiss authorities.

3.2 Market surveillance and inspections

The Liechtenstein Drug Control Service has the competence to carry out inspections within the meaning of Art. 6, para. 2, 19, para. 3, 28, para. 4 and 34, para. 3, LPTh. Inspections are carried out by bodies recognised by Swissmedic, the Swiss Institute for Therapeutic Products.

Formal market surveillance within the meaning of s. 58 LPTh falls within the competence of the Liechtenstein drug control service, which works closely with Swissmedic, the Swiss Institute for Therapeutic Products, in particular with regard to the duty of information within the meaning of Art. 58, para. 5, LPTh.

3.3 Administrative measures

Within the limits of its powers, the Liechtenstein drug control service shall take the necessary measures within the meaning of Art. 66 LPTh. The competent Swiss authority shall inform its customs authorities that they must make use of the Liechtenstein drug control service under Art. 66, para. 4, LPTh when an addressee or a Liechtenstein transmitter is involved.

4. Collaboration between the Swiss authorities and the relevant Liechtenstein authorities, exchange of information

The competent authorities of Switzerland and Liechtenstein shall provide each other with the information necessary for the implementation of this Agreement.

5. Entry into Force and Termination

If these provisions meet the approval of the Swiss Federal Council, the present note and the response note from Switzerland constitute an agreement between the two governments, which will enter into force on 1 ^Er January 2002.

This Agreement may be terminated at any time by each of the Contracting Parties subject to twelve months' notice.

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."

The Federal Department of Foreign Affairs has the honour to bring to the knowledge of the Embassy of the Principality of Liechtenstein that the Swiss Federal Council gives its approval under this note, which is therefore, with the present Response, an agreement between the two governments coming into force on 1 ^Er January 2002.

The Federal Department of Foreign Affairs also takes this opportunity to renew to the Embassy of the Principality of Liechtenstein the assurance of its high regard.