Hey @Infoseeker, Section 3 of the Food and Drug Act, prohibits advertising to the general public of any drug (whether Rx or non-Rx) as a treatment for a disease listed in Schedule A. Promotion of drugs for prevention of Schedule A does not contravene this section of the Act. The Food and Drug Regulation C.01.004 also states that where a person advertises to the general public a prescription drug, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantify of the drug. If the brand falls into these categories, then yes, a gate would be required.

@Jennifer-Carroll Ah. Thanks for clarifying. I misunderstood that question 466 was in relation to attaching an approved template, and not just for a regular email. Thanks for the quick response!

Hey @Helen Section 6.6 was revised and repositioned to 1.5. Alternatively, this may have been a typo in the response letter. Please follow up with your reviewer if section 1.5 does not address the issue. With regards to archived versions of the Code, per PAAB Q&A 717, the PAAB website only contains the most recent version of the code so as to clearly promote current best practices.

Hi @Sil No, it is not required that medical/regulatory staff review the translation. As a reminder, Code s.1.4G states “The sponsoring company shall be responsible for accuracy of translation of APS".

Good Morning @rcolbear As per “Chapter 4. Post Approval” in the document “Guidance on Submission Process”, a request for extension can be submitted for assessment. An annotated copy of the product monograph with all changes since the previous TMA should be uploaded. The PAAB will make an assessment to see if the changes to the product monograph impact the piece. It is possible for changes deemed to be “minimal” by the sponsor, to still have a meaningful impact on the piece. Upon PAAB assessment, if the piece is still deemed to meet the requirements of the Code, a maximum 2 month extension can be granted. Note that it is the responsibility of the manufacturer to ensure that they are not using a piece which is inconsistent with PM updates occurring during approval and/or extension periods. Thank you for the question.

Hey @SKW We did some digging and here's what we found: In the last 6 months, there have been approximately 4087 distinct APS submitted for review from 65 manufacturers. Of these, 87 (just over 2%) were submitted directly from 6 manufacturers. Of these, 2 manufacturers did not use an agency at all during that period.

Hey @AnetteCPC This would not be acceptable as the cookies would be placed on the computer, but they would not be able verify who is using that computer. If an HCP was to sign into a verified site on a shared computer, sign out and leave that computer, the next user would be exposed to advertising without verification that they are an HCP. This would contravene consumer regulations.