Product development and regulatory affairs consultancy for the animal health industry

News from the Regulators

21 August 2019 | Brexit

EC reiterates need to transfer batch testing activities by 1 January 2020

With less than three months remaining until the current deadline for the UK to leave the EU, the European Commission has reiterated the need for all batch testing facilities to be fully transferred to the EU27/EEA by 1 January 2020...

21 August 2019 | Latest info

Summer activity at the EMA sees news of paromomycin referral, PSUR contact points and a new quality Q & A

Over the holiday period, there have been a few general updates from the EMA as well as news of the paromomycin referral, updated PSUR submission guidance and a Q & A on manufacture of active substances...

17 July 2019 | Latest info

Life-cycle management Q&A for VMPs, the new veterinary regulation and other news from the EMA

A raft of updated question and answers pages has been published on the EMA website, addressing all aspects of life-cycle management for VMPs. There has also been news on the use of tylosin in sheep, the development of new antibiotics and the NVR...

Training

to be confirmed | to be confirmed

Product development and regulatory affairs consultancy for the animal health industry

Pharmaceuticals

Immunologicals

Feed Additives

News from the Regulators

EC reiterates need to transfer batch testing activities by 1 January 2020

Summer activity at the EMA sees news of paromomycin referral, PSUR contact points and a new quality Q & A

Life-cycle management Q&A for VMPs, the new veterinary regulation and other news from the EMA

Training

Development & Registration of Novel Veterinary Therapies

Veterinary Medicines for Minor Use / Minor Species (MUMS): practical advice and available incentives

Referrals for Veterinary Medicinal Products (VMPs)