Guidelines

On 25 November 2013, the European Commission published an Implementing Decision containing guidelines to assist responsible persons comply with their regulatory obligations under the EU Cosmetics Regulation (EC) No 1223/2009 (Cosmetics Regulation).  The guidelines provide clarity on Annex I of the Cosmetics Regulation, which sets out the minimum requirements for cosmetic product safety reports.  The Implementing Decision will enter into force in mid-December 2013.

Under the Cosmetics Regulation, cosmetic products placed on the EU market must be safe for human health when used under normal and reasonably foreseeable conditions of use, taking into account, among other things, the product’s presentation and labelling.  A legal or natural person designated within the EU as the “responsible person” must ensure that each cosmetic product placed on the EU market has a cosmetic product safety report drawn up in accordance with the requirements of Annex I of the Cosmetics Regulation.  This safety report forms part of the product’s information file, which the responsible person must keep for a period of 10 years following the placing on the market of the last batch of product.Continue Reading EU Guidelines on Cosmetic Product Safety Reports

On 15 November 2013, the EMA released the first draft product-specific guidance documents on the demonstration of bioequivalence for 16 active substances for public consultation.

This first set of guidance builds upon the general principles set out in the Agency’s Guideline on the investigation of bioequivalence of 2010, which specified the requirements for the design, conduct and evaluation of bioequivalence studies for immediate release dosage forms with systemic action.  These first guidance documents will be followed by another wave of product-specific guidance in the course of 2014.
Continue Reading EMA Releases Its First Product-Specific Guidance on the Demonstration of Bioequivalence for Public Consultation

EMA has published a draft guideline on the use of phthalates as excipients in human medicinal products. The guideline establishes new Permitted Daily Exposure (“PDE”) values for the following phthalates that are among the most commonly used as excipients in medicinal products:

  • dibutyl phthalate: 0.01 mg/kg/day
  • diethyl phthalate: 4 mg/kg/day
  • polyvinyl acetate phthalate: 2 mg/kg/day

The guideline also concludes that data currently available for cellulose acetate phthalate and hydroxypropyl methylcellulose acetate phthalate do not indicate that their presence in human medicinal products constitutes a potential risk for human safety.
Continue Reading EMA Publishes Draft Guideline on the Use of Phthalates in Medicines