22001D0203(01)

Decision No 1/2000

of 12 December 2000

of the Joint Committee established under the Agreement on Mutual Recognition between the European Community and the United States of America related to amending the Sectoral Annexes on telecommunication equipment, electromagnetic compatibility, pharmaceutical GMPs and medical devices

(2001/90/EC)

THE JOINT COMMITTEE,

Having regard to the Agreement on Mutual Recognition between the European Community and the United States of America, and in particular Article 14 and 21 thereof,

Whereas:

(1) The Agreement should be amended to reflect changes in their respective legislation.

(2) Pursuant to Article 21(2) any Sectoral Annex may, through the Joint Committee, be amended in writing by the Parties,

HAS DECIDED AS FOLLOWS:

1. Amendments to the Sectoral Annex for telecommunications equipment

The Sectoral Annex for telecommunication equipment is amended according to the following:

(a) In Section I, under the EC column, the entire text is deleted and is replaced with the following:

"Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity".

(b) In Section III, paragraph 2(c), "Directive 98/13/EC" is deleted and replaced with "Directive 1999/5/EC".

(c) In Section III, paragraph 2, the following subparagraphs are added:

"(d) prescription of radio tests to be performed pursuant to Annexes III and IV to Directive 1999/5/EC;

(e) issuing of an opinion on a technical file pursuant to Annex IV to Directive 1999/5/EC."

(d) In Appendix 1, "ACTE Approval Committee for Terminal Equipment", "ADLNB Association of Designated Laboratories and Notified Bodies" and "CTR Common Technical Regulations" are deleted.

2. Amendments to the Sectoral Annex for electromagnetic compatibility (EMC)

In Section IV, under the "US" column, "Federal Aviation Administration (FAA)" is deleted.

3. Amendments to the Sectoral Annex for pharmaceutical good manufacturing practices (GMPs)

Article 1, paragraph 3 is deleted in its entirety and is replaced with the following text:

"3. Good Manufacturing Practices (GMPs)

In the United States, GMPs means the requirements found in the legislation, regulations and administrative provisions for methods to be used in, and the facilities or controls to be used for, the manufacturing, processing, packing, and/or holding of a drug to assure that such drug meets the requirements as to safety, and has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess.

In the EC, GMPs are the part of quality assurance which ensures that products are consistently produced and controlled to a quality standard. GMPs include, therefore, the system whereby the manufacturer receives the specifications of the products and/or process from the marketing authorisation/product authorisation or license holder or applicant and ensures the product is made in compliance with its specifications (qualified person certification).

Because equivalence is the cornerstone of this Annex, the authorities of the Parties will maintain their respective requirements and will carry out the inspections against their own requirements."

4. Amendments to the Sectoral Annex for medical devices

The Sectoral Annex for medical devices is amended according to the following:

(a) Table 1 is deleted in its entirety and is replaced with the revised Table 1, annexed hereto.

(b) Table 2 is deleted in its entirety and is replaced with the revised Table 2, annexed hereto.

This Decision, done in duplicate, shall be signed by representatives of the Joint Committee who are authorised to act on behalf of the Parties for purposes of amending the Agreement. This Decision shall be effective from the date of the later of these signatures.

Done at Washington DC, 12 December 2000.

On behalf of the United States of America

Charlene BARSHEFSKY

Done at Brussels, 21 November 2000.

On behalf of the European Community

Pascal LAMY

ANNEX

TABLE 1

Class I products requiring premarket evaluations in the United States, included in scope of product coverage at beginning of transition period

DENTAL PANEL

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1.1. GASTROENTEROLOGY / UROLOGY PANEL

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GENERAL AND PLASTIC SURGERY PANEL

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GENERAL HOSPITAL

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NEUROLOGY PANEL

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OBSTETRICS AND GYNECOLOGY PANEL

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OPHTHALMOLOGY PANEL

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ORTHOPAEDIC PANEL

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PHYSICAL MEDICINE PANEL

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RADIOLOGY PANEL

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TABLE 2

Class II medical devices included in the scope of product coverage at beginning of transitional period

(United States of America to develop guidance documents identifying US requirements and EC to identify standards needed to meet European Union requirements)

ANESTHESIOLOGY PANEL

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CARDIOVASCULAR PANEL

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DENTAL PANEL

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GASTROENTEROLOGY/UROLOGY PANEL

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GENERAL HOSPITAL

>TABLE>

NEUROLOGY PANEL

>TABLE>

OBSTETRICS AND GYNECOLOGY PANEL

>TABLE>

OPHTHALMOLOGY PANEL

>TABLE>

ORTHOPAEDIC PANEL

>TABLE>

RADIOLOGY PANEL

>TABLE>

GENERAL AND PLASTIC SURGERY PANEL

>TABLE>