Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No .../2000 on substances that deplete the ozone layer as regards metered dose inhalers and medical drug pumps

(presented by the Commission)

EXPLANATORY MEMORANDUM

This proposal for a Regulation of the European Parliament and of the Council amending the Regulation on substances that deplete the ozone layer as regards metered dose inhalers and medical drug pumps is necessary because in the final stages of the adoption of the Regulation two issues have emerged as a result of inconsistencies in the text. The first refers to the export of metered dose inhalers containing chlorofluorocarbons (CFCs) to developing countries and the second to the export of medical drug pumps containing CFCs.

It has never been the intention of the Commission, or that of the Council and the European Parliament, to ban the export of such products that are still needed for health reasons in such countries.

The proposed amendments would not conflict with the European Community's obligations under the Montreal Protocol.

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No .../2000 on substances that deplete the ozone layer as regards metered dose inhalers and medical drug pumps

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,

Having regard to the proposal from the Commission [1],

[1] OJ C

Having regard to the opinion of the Economic and Social Committee [2],

[2] OJ C

Having regard to the opinion of the Committee of the Regions [3],

[3] OJ C

Acting in accordance with the procedure laid down in Article 251 of the Treaty [4],

[4] OJ C

Whereas:

(1) Exports of metered dose inhalers to developing countries and exports of medical drug pumps containing chlorofluorocarbons are not allowed under Regulation (EC) No .../2000 of the European Parliament and of the Council of ... on substances that deplete the ozone layer [5]. However, the export of these health products, which can be used in the Community market, should not be restricted.

[5] OJ L

(2) Regulation (EC) No .../2000 should, therefore, be amended accordingly,

HAVE ADOPTED THIS REGULATION:

Article 1

The following point (f) is added to Article 11(1) of Regulation (EC) No .../2000:

"(f) metered dose inhalers and delivery mechanisms containing chlorofluorocarbons for hermetically sealed devices for implantation in the human body for delivery of measured doses of medication which under Article 4(1) can be given a temporary authorisation in accordance with the procedure referred to in Article 18(2)."

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

IMPACT ASSESSMENT FORM THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE TO SMALL AND MEDIUM-SIZED ENTERPRISES( SMEs)

Title of proposal

Draft Proposal for a Regulation concerning metered dose inhalers and medical drug pumps containing CFCs, amending Regulation (EC) No .../2000 on substances that deplete the ozone layer.

Document reference number

Regulation (EC) No .../2000 of the European Parliament and of the Council

The impact on business

This amendment would be beneficial to the European pharmaceutical industry in that it would provide the legal certainty that they could continue to export metered dose inhalers and medical drug pumps both of which contain CFCs. These are important health products and in particular as regards MDIs, the European Community industry is one of the most important suppliers to other countries' markets.