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The Irish Medicines Board -

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IMB Newsletter Issue No. 34 September - December 2009

09 February 2010

IMB Newsletter Issue No. 34 

Human Medicines

- Electronic submission of responses
- Herbal medicinal products
- Method of sale, supply and promotion
- Use of colour on labelling
- New EudraVigilance business rules
- Homeopathic Medicines National Rules Scheme

Veterinary Medicines 

- Advance notice of requirement to provide information on usage of antimicrobial medicines
- Changes to joint IE/UK procedures
- IMB Veterinary Information Day
- Withdrawal period for injectable products containing Ivermectin in cattle
- Availability of veterinary medicinal products for minor use in Ireland
- Possible revision to the EU Directives governing the authorisation of veterinary medicinal products


- Guidance document for variations to Manufacturer's/Wholesaler's Authorisations
- Revised format for Manufacturer's/Importer's Authorisation (MIA)
- Electronic applications for Authorisations / Certificate of Pharmaceutical Product (CPP) / GMP certificates
- Payment of fees relating to Authorisations, Export Certificates etc
- Charges relating to third country inspections
- GDP Information Day
- Robberies at manufacturing sites
- Drug precursors
- GMP updates

Date Printed: 17 April 2014

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