Regulatory services for Prescription and Non Prescription Medicines

By: Carsl Consulting  06-Dec-2011
Keywords: Product Development

Both Prescription and Non-prescription (OTC) medicines require approval by Medsafe before they can be distributed in New Zealand.  Additionally, medicines with approval that undergo material changes may also require Medsafe approval through a Changed Medicine Notification before these changes can take effect.  We can advise you about getting your product approved and maintaining the currency of the registration.  We offer:

  • Advice and co-ordination for product development or product sourcing
  • New Medicine Application preparation, submission and follow-up 
  • Changed Medicine Notification preparation, submission and follow-up
  • Preparation of medicine datasheets and consumer medicine information
  • Advice concerning product labelling and advertising
  • Applications for Clinical Trials
  • Product Sponsorship

Keywords: Product Development

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Other products and services from Carsl Consulting

06-Dec-2011

Complementary Medicines

We take every opportunity to provide input into proposed regulations and guidelines for complementary medicines and products at the food/medicine interface and can provide advice concerning forthcoming regulatory requirements. While we support the regulation of complementary medicines in New Zealand, we recognise that such regulation should take into account the nature of the product and of inherent risks involved in their use.


06-Dec-2011

Medical Devices

We take every opportunity to provide input into proposed regulations and guidelines for medical devices and can provide advice on the regulatory controls as they become apparent. The regulatory controls on medical devices were expected to increase significantly on commencement of the Australia New Zealand Therapeutic Products Authority.


06-Dec-2011

In-Vitro Diagnostics

There is now uncertainty regarding the future of ANZTPA but it is expected that in-vitro diagnostics will eventually come under some regulatory controls in the future. Under the proposed Australia New Zealand Therapeutic Products Authority in-vitro diagnostics would be controlled in a similar fashion to medical devices. We can provide advice on the regulatory controls as they become apparent to ensure compliance for your in-vitro diagnostics.


06-Dec-2011

Pfizer Chemicals

We also supply full technical support for ingredients supplied in New Zealand and can handle any regulatory aspects involved with their use. CARSL Consulting is the New Zealand agent for the Pfizer Centre Source range of pharmaceutical active ingredients. These include corticosteroids, hormones and antimicrobials.