HPRA Medicinal Products Newsletter - Issue Number 58
Download:
hpra-medicinal-products-issue-number-58-final.pdf
2 MB
In This Issue:
Human Medicines
- Follow-up of adverse reaction reports
- Audits of type IA notifications:2016/2017 review
Veterinary Sciences
- HPRA veterinary science information day 2018
- Brexit update
- Joint-labelling of veterinary medicines
- Response to HPRA survey on Irish language information
- Updating the SPC as a result of a variation
- Staff changes in the veterinary medicines team
Compliance
- Cosmetic products notification portal
- Understanding and using CosIng – the Cosmetic Ingredient Database
- Temperature mapping in storage areas for medicinal products
- Submission of annual returns – controlled drugs
- Submission of Annual Returns – precursor chemicals
- Precursor chemical regulatory update
- Misuse of Drugs legislative amendments
- Safety features and the impact on wholesale distribution authorisation (WDA) holders
- GMP Guidance for consultation
- Update on regulatory oversight of outsourced storage of stability samples
- New regulatory approach for contract laboratories
- Brexit: Transfer of responsibility for EU batch certification and wholesaling activities
« Back