Pharmacovigilance GCC Certification
Our client was a manufacturer of medical devices from the UK. They had a unique requirement for a single product category to add storage conditions to the product labelling of their contact lens product in one specific geographic region.
The Problem
The labelling requirement was only for contact lenses sold into the United Arab Emirates. It would have been simple enough to create a new label and have this approved, but the client was unwilling to go through the trouble and cost of having their global label changed in any way since it was already registered and approved worldwide.
Another problem was that the regulators would not accept a sticker to be placed on the outer package, adding storage conditions to the packaging.
To summarize the challenge, we needed to add storage conditions to the packaging on products destined for the UAE market.
- Published in courses
Medical Device Regulation Master class-MENA
Our client was a manufacturer of medical devices from the UK. They had a unique requirement for a single product category to add storage conditions to the product labelling of their contact lens product in one specific geographic region.
The Problem
The labelling requirement was only for contact lenses sold into the United Arab Emirates. It would have been simple enough to create a new label and have this approved, but the client was unwilling to go through the trouble and cost of having their global label changed in any way since it was already registered and approved worldwide.
Another problem was that the regulators would not accept a sticker to be placed on the outer package, adding storage conditions to the packaging.
To summarize the challenge, we needed to add storage conditions to the packaging on products destined for the UAE market.
- Published in courses
Intellectual Property Rights (IPR) for Pharmaceutical Industry in the GCC
Our client was a manufacturer of medical devices from the UK. They had a unique requirement for a single product category to add storage conditions to the product labelling of their contact lens product in one specific geographic region.
The Problem
The labelling requirement was only for contact lenses sold into the United Arab Emirates. It would have been simple enough to create a new label and have this approved, but the client was unwilling to go through the trouble and cost of having their global label changed in any way since it was already registered and approved worldwide.
Another problem was that the regulators would not accept a sticker to be placed on the outer package, adding storage conditions to the packaging.
To summarize the challenge, we needed to add storage conditions to the packaging on products destined for the UAE market.
- Published in courses
Professional Regulatory Affairs GCC Certification
Our client was a manufacturer of medical devices from the UK. They had a unique requirement for a single product category to add storage conditions to the product labelling of their contact lens product in one specific geographic region.
The Problem
The labelling requirement was only for contact lenses sold into the United Arab Emirates. It would have been simple enough to create a new label and have this approved, but the client was unwilling to go through the trouble and cost of having their global label changed in any way since it was already registered and approved worldwide.
Another problem was that the regulators would not accept a sticker to be placed on the outer package, adding storage conditions to the packaging.
To summarize the challenge, we needed to add storage conditions to the packaging on products destined for the UAE market.
- Published in courses