Publication of the amendment of the natural medicinal products and traditional herbal medicinal products 1)

§ 1

Notice no. 1233 of 12. In December 2005 on the herbal medicinal products and traditional herbal medicinal products, the following changes shall be made :

1. Foot notation to the notice title ITREAS :

" 1) The commotion contains provisions that implement parts of Directive 2001 /83/EC of the European Parliament and of the Council of 6. November 2001 establishing a Community code of medicinal products for human use, the Official Journal of the European Communities. L 311, s. Last amended by Directive 2010 /84/EU of the European Parliament and Council Directive 2010 /84/EU of 15. December 2010, EU Official Journal, nr. L 348, s. Directive 74, and the European Parliament and Council Directive 2011 /62/EC of 8. June 2011, EU Official Journal, nr. In 174, s. 74. "

2. § 2, nr. 1, ITREAS :

" 1) If active components are not exclusively-isolated substances of natural origin. '

3. § 17, paragraph 1. 3, ITREAS :

" Stop. 3. § 9, § 14, § 15, § 17, § 17a, § 27, paragraph 1. 1-4, section 28, section 33, section 35, section 36, § 38, § 41, § 44, § 46, § 58, § 72, paragraph 72. 1, no. One and two, section 72, paragraph. 2, section 92c and section 92d, in the Act of Medicinal Products, shall apply mutatis mulations to records in accordance with this Chapter ' ;

4. I § 17 pasted as paragraph FOUR :

" Stop. 4. The registration holder for a traditional herbal medicinal product shall, if the Board of Health, on the basis of concerns relating to pharmacovigilance data, shall submit periodic safety updates to the medicinal product. The periodic safety updates must meet requirements for content and requirements laid down in accordance with section 53 (3). '4, and Article 56a, in the law on medicinal products, and requirements for content and format laid down by the European Commission.'

5. § 22 revoked.

§ 2

The announcement shall enter into force on 3. August 2012.

1) The commotion contains provisions that implement parts of Directive 2001 /83/EC of the European Parliament and of the Council of 6. November 2001 establishing a Community code of medicinal products for human use, the Official Journal of the European Communities. L 311, s. Last amended by Directive 2010 /84/EU of the European Parliament and Council Directive 2010 /84/EU of 15. December 2010, EU Official Journal, nr. L 348, s. The Directive 74 and the European Parliament and Council Directive 2011 /62/EC of 8. June 2011, EU Official Journal, nr. In 174, s. 74.