Have you attempted to terminate those dormant product licenses, only to discover that there’s no clear decision maker for these licenses within the company?
It’s quite understandable that these dormant licenses might still be causing you headaches, much like persistent zombies that just won’t quit.
I must emphasise that I don’t intend to cast blame on the decision-makers. Cancelling intellectual property is indeed a weighty choice. However, if they were fully aware of the comprehensive impact that retaining these licenses can have, their decision might become significantly easier.
Below, I’ve outlined a few of the potential repercussions that these dormant product licenses can impose on your resources and costs:
🔹Regulatory Authority Maintenance Fees
🔹Pharmacovigilance services
🔹PSUR submissions as required by the EURD List
🔹Reporting ADRs to Regulatory Authorities every 15 days
🔹SPC submissions, each section incurring a fee
🔹PIL changes involving artwork design and submission
🔹PIL readability improvements as needed
🔹Adjustments to cartons/labels mandated by regulators
🔹API supplier audits, with costs shared across MA Holders
🔹Maintenance of Marketing Authorisation (MA) in international markets, despite non-marketing status
🔹Continued license maintenance, including updates like CEP changes
🔹Regulatory resources expenditure
🔹Batch Card maintenance
🔹Maintenance of QC Specifications
🔹Timing coordination with the Change Control Committee
🔹Upkeep of component specifications, potentially including component inventory
🔹Updates to data systems as necessary
🔹Maintenance of supplier audit status, encompassing on-site audits
🔹Product Quality Reviews (PQRs) that remain essential, albeit brief
🔹Preservation of manufacturing capability/equipment and validation status
🔹Revisions to technical agreements, SOPs, etc., wherever references appear in documents
🔹Expenses related to document archiving and retention
Typically, those of us in regulatory roles tend to focus on the seemingly inconsequential annual authority fees. Yet, when you broaden your perspective to encompass the holistic impact on the entire business, the decision becomes remarkably clear.
Anticipate my forthcoming email, in which I’ll guide you through strategies to simplify and streamline the review process.
In the interim, if you’re interested in optimising your portfolio, consider scheduling a call using the link below. This step could yield substantial savings in terms of time, energy, and finances. Elevating your department’s efficiency to new heights is within your grasp.
Click here to book your call now
In this concise yet impactful call, we’ll:
🔍 Learn about your business and the regulatory challenge at hand.
🎯 Gain a crystal-clear view of your goals and identify potential regulatory hurdles.
🔧 Develop tailored regulatory solutions to tackle your most pressing challenges.
Best Regards,
Aziz
#RegulatoryAffairs #Pharmaceuticals #Efficiency #BusinessStrategy