Reply To: CR Clinical Packaging Requirements

Brian Sheridan

Reply To: CR Clinical Packaging Requirements

Hi David & Rhys

Apologies only seen this email trail. We supply CR-SF packaging from both USA and EU locations. Please see below from our regulatory lead:

In Canada certain drug products require special packaging (see Canada Food and Drug Regulations CRC c.870 Section C01.002 and CAN/CSA-Z76.1-M90).

Canada has its own testing standards (see CAN/CSA-Z76.1-06 (R2016) – Child Resistant Packaging; CAN/CSA Z76.2-00 – Child Non-reclosable Resistant Packages; CAN/CSA-Z76.1-99 (R2003) – Child Reclosable Resistant Packages) and as I understand, will also accept US testing standards (since they are arguably more stringent).

Products that require CR packaging include drugs that contain:
• salicylic acid, a salt thereof or salicylamide, acetylsalicylic acid, or any of its salts or derivatives, acetaminophen, or more than five per cent alkyl salicylates,
• certain Vaping products
• drugs recommended solely for children.

Where the drug is not recommended solely for children, at least one of the sizes of packages available for sale must be packaged in a child resistant package, and vaping products. Where these drugs are packaged in a package that is not a child resistant package as permitted by Canadian law, the outer label must carry a statement that the drug is available in a child resistant package.

Trust this is of some help and should you wish to dicuss furhter please do not hesitate to get in contact via my email address below.

Brian Sheridan
VP GlobalAdherence WestRock