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Any changes which are necessary in order to adapt Annex I to take account of scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 121(2).
1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use, hereinafter called ‘ the Standing Committee ’ , in the task of adapting to technical progress the directives on the removal of technical barriers to trade in the medicinal products sector.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.
4. The Standing Committee shall adopt its own rules of procedure which shall be made public.]