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Selling to Greek Public Hospitals: EKAPY Tenders and Centralised Procurement
Reimbursement approval gets a medicine onto the Greek positive list. It does not get it into a public hospital. That last step runs through a[…]
Quality Risk Management After ICH Q9(R1): Formality, Subjectivity and the Chapter 1 Rewrite
Quality risk management has been a GMP expectation since 2006, but the revised ICH Q9(R1) — effective in the EU since 26 July 2023 —[…]
Veterinary Product Information: Getting the SPC, Label and Package Leaflet Right
Product information for a veterinary medicine has to work for readers who are not clinicians. A farmer calculating a dose for a group of animals,[…]
Veterinary Pharmacovigilance Inspection Readiness: What Gets Tested
A veterinary pharmacovigilance inspection is not a document review. It is an attempt to establish whether the system described on paper is the system that[…]
Wholesale Distribution of Veterinary Medicines: GDP Obligations Along the Chain
A veterinary medicine can be manufactured under impeccable conditions and still reach the animal in an unusable state. Regulation (EU) 2019/6 places distribution under its[…]
The Veterinary QPPV: More Than a Name on a Form
Every marketing authorisation holder with veterinary products needs a qualified person responsible for pharmacovigilance. The role is easy to fill badly: a name entered on[…]
Environmental Risk Assessment for Veterinary Medicines: VICH GL6, GL38 and the Two-Phase Model
Veterinary medicines reach the environment by routes that human medicines largely do not: through manure spread on land, through direct excretion at pasture, through aquaculture[…]
The Veterinary Dossier Under Annex II: What Delegated Regulation (EU) 2021/805 Expects
The technical content of a veterinary marketing authorisation application is governed by Annex II to Regulation (EU) 2019/6, as replaced by Commission Delegated Regulation (EU)[…]
Authorising a Veterinary Medicine in Greece: Routes, Authority and Local Practicalities
Companies bringing a veterinary product into Greece often assume the process mirrors the human medicines pathway they already know. Much of it does. The National[…]
Selling Veterinary Medicines Online: Article 104 and the EU Common Logo
Retail of veterinary medicinal products at a distance is permitted across the EU, but on defined terms. Article 104 of Regulation (EU) 2019/6 sets the[…]