Quarter 2 Newsletter 2024
- US State reporting calendar: April 2024 -June 2024
- US updates: California & New Jersey privacy laws, DOJ voluntary self-disclosure policy
- EU & global reporting calendar: April 2024 -June 2024
- EU & global updates
- Compliance commentary
Marking the conclusion of the US Federal reporting deadline, our attention pivots towards the global obligations looming over pharmaceutical and medical device companies in the second quarter of 2024. As the baton passes from one set of deadlines to another, let’s explore the intricate web of international compliance requirements awaiting our engagement.
Before we delve into global matters, let’s begin with the US obligations. The FDA Pharma Sample Report is due on 1st April. It involves submitting annual reports to the FDA. The FDA has also provided guidance on how to make a disclosure which will be useful to those who have a requirement to report.
Moving on to State reporting and License deadlines, there are several to meet this semester. Oregon Pharmaceutical Manufacturers’ Representatives disclosure report is due on 1st April as well as the Vermont disclosure report which is required to be submitted by both Pharmaceutical & Medical Device Manufacturers. A reminder to those who will be making a disclosure for Vermont that you are also required to complete a Compliance Officer Form online and make a payment in the sum of $500. Lastly for the month of April we have Manufacturers of certain prescription drugs identified by Nevada who must submit a pricing and sales report annually by April 1st.
Continuing from April and heading into May we have the Pharmaceutical Manufacturers Disclosure Report for Minnesota to be disclosed on 1st May. Moving on to Licences and Registrations, the Minnesota Drug Manufacturers’ License is due on 1st June. Drug manufacturers are required to obtain a license from the Minnesota Board of Pharmacy on a yearly basis. The Marketing Code of Conduct Annual Filing Form (Formerly referred to as AB128. Revised 2023) is also due on 1st June, ending with the Connecticut Pharmaceutical Marketing Firm Registration that is due on 30th June.
Numerous deadlines on the global front during this quarter create a busy period for companies with global reporting obligations, particularly through EFPIA and MedTech. Monthly disclosure reports for Indonesia and Portugal are once again due, followed by Belgium and The Netherlands on May 31st.
Moving into the month of June, which encompasses the majority of the deadlines, we begin with Estonia, which has a deadline for pharmaceutical companies on June 1st. Following that, we have the following countries with a reporting deadline on June 30th; Estonia (Medical device) companies, Greece, UK, Luxembourg, Austria, Bulgaria, Croatia, Cyprus, Finland, Czech Republic, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Poland, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, Iceland, New Zealand, Slovakia, Mexico.
Companies that are members of MedTech or EFPIA, or if they belong to a local association that is a member of MedTech and EFPIA, are also required to make disclosures by June 30th.
Proceeding in to some global updates, The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) conducted a consultation regarding changes to the pharmaceutical industry code of practice which ended on 29th February 2024.
The updated 2024 ABPI Code of Practice is expected to be published in the second quarter of 2024 and will go into effect three months after publication. Until the 2024 ABPI Code of Practice is published, the 2021 ABPI Code of Practice will remain in effect.
A gentle reminder that comprehensive reporting requirements for both the US and global are outlined in detail within the Quarter 2 MedPharma Transparency Newsletter.
If you express interest in arranging a meeting with our esteemed LegalEZ™ team to dive deep into our newsletter, then we invite you to contact us at your earliest convenience. Your inquiry is highly valued, and we look forward to the opportunity to assist you further.