Consultation Deadlines

27th August 2019
31st August 2019
EMA Scientific guideline: Draft guideline on data requirements for veterinary medicinal products for the prevention of transmission of vector-borne diseases in dogs and cats, draft: consultation open.

EMA Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances – Revision 1, draft: consultation open.

EMA Scientific guideline: Reflection paper on resistance in ectoparasites, draft: consultation open.

EMA Scientific guideline: Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), draft: consultation open.

EMA Scientific guideline: Reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products, draft: consultation open.

EMA Scientific guideline: Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products, draft: consultation open.

EMA Scientific guideline: Revised guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, draft: consultation open.

EMA Scientific guideline: Guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats, draft: consultation open.

EMA Scientific guideline: Guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances, draft: consultation open.

EMA Scientific guideline: Draft guideline on the quality requirements for drug-device combinations.

1st September 2019
3rd September 2019
9th September 2019
10th September 2019
16th September 2019
25th September 2019
29th September 2019
30th September 2019
9th October 2019
15th October 2019
30th October 2019
31st October 2019
6th November 2019