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Applicants/ PHCR

Communications to industry

Communications to all stakeholders

Guidelines - Veterinary Medicines

Manufacturers, Laboratories, Importers, Exporters

Category List(s)

Applicants/ PHCR

Communications to industry

New safety information on the use of SSRI'S in children under the age of 18 years (MS-Word 45kb)

Safety update of selective serotonin reuptake inhibitors (SSRIS) (MS-Word 51kb)

Scheduling matters - accessibility of malaria prophylaxis medicines (Ms-Word 214kb)

Scheduling of Pseudo Ephedrine, BZP April 08 (PDF 70kb)

Standard package insert information: known symptoms of paracetamol overdosage and particulars of its treatment (MS-Word 64bk)

Standardised information to be included in the package inserts for non-selective NSAIDs and COX-2 inhibitors (Ms-Word 76kb)

Standardised wording for contra-indications for the use of ace inhibitors and angiotensin receptor blockers (ARBs) (MS-Word 64kb)

Vitamin A indications (MS-Word 53kb)

Warning on hyperglycaemia and diabetes mellitus with atypical antipsychotic agents (MS-Word 44kb)

Communications to all stakeholders

9.01 - Antiretrovirals registered by the medicines control council for the period 1989-2004 (MS-Word 117kb)

9.25 - Applications for registration of Medicines Containing Enoxaparin

9.26 - Request for information on Non-finalized Applications (MS-Word 130kb)

9.28 - Cancellation and withdrawal of applications or registered Medicines

9.30 - Clinical Trials submission dates for 2010 (MS-Word 56kb)

Cisapride-containing products (prepulsid) (MS-Word 52kb)

Due date for submission of clinical trial applications (Ms-Word)

Review of generic substitution guideline list of non-substitutable medicines (Ms-Word 45kb)

Guidelines - Veterinary Medicines

Bioavailability and Bioequivalence of veterinary medicines (zipped MS-Word 65kb)

Efficacy of and GCP for veterinary medicines (zipped MS-Word 35kb)

Efficacy of veterinary Biolologicals (zipped Ms-Word 32kb)

General Information (zipped MS-Word 121kb)

Guideline on preclinical safety studies for veterinary medicines (zipped MS-Word 35kb)

MRLS and withdrawal periods (zipped MS-Word 75kb)

safety of veterinary Biologicals (zipped MS-Word 35kb)

Section 21 applications for unregistered veterinary medicines (zipped MS-Word 108kb)

Veterinary Drug Recalls (zipped MS-Word 32kb)

Manufacturers, Laboratories, Importers, Exporters