Why does the office reject technical documentation?
It's a frustrating feeling when, after 7 months of waiting for a decision, a refusal letter lands on your desk. At SanofyvisionIndia Pharma Relations, we have carefully analyzed 12 such cases from the last six months. Most of these errors could have been caught in 15 minutes before sending the documents to the office, saving thousands of PLN and the whole team's nerves.
Numbers in chemistry know no mercy
Officials at the Ministry of Health and URPL look primarily at hard data. If you enter an active substance concentration of 4.97 mg in your technical documentation, and the attached analytical certificate shows 5.01 mg, you are almost guaranteed a call for explanation. For someone outside the industry, this difference is negligible, but in the registration process, it's a signal that quality control at the manufacturer may be leaky. In October 2024, we saved an application of a company from Poznań where the discrepancy was only 0.04 mg in one of the pilot batches.
The problem is that such corrections hold up the procedure for long weeks. We had to prepare 14 pages of additional technical explanations and analytical method validation reports to untangle this situation and prove that the error was purely editorial. According to the act, every digit in the dossier must have its backing in raw data from the laboratory. Since September 2016, at SanofyvisionIndia Pharma Relations, we have applied the triple tabular verification rule. Every number passes through the hands of three different analysts before it reaches the final printout.
Also pay attention to product stability. Companies often attach stability test results that end at the 23rd month but declare a 24-month validity period. The office will not accept a promise that 'nothing will happen during this last month'. You must have proof on paper. In 2024, we recorded 7 cases where the lack of one partial stability test report at 25 degrees Celsius caused the rejection of the entire Module 3 of the dossier.
Even a difference of 0.04 mg in active substance concentration can block a drug's market entry for another 6 months.
The trap of imprecise translation
This is one of the most common sins we see. You often outsource dossier translation to someone who knows English perfectly but has never worked in the pharma industry. The word 'tablet' is not the same as 'lozenge' in Polish pharmaceutical law. Due to one imprecise term 'sustained release' translated as 'long-acting' instead of the correct 'extended-release', the office suspended a client's procedure for exactly 112 business days. The official decided that the description suggested a different pharmacological action than what resulted from the product characteristics.
Always check whether the translator has a medical translator certificate or at least 4 years of experience in registration projects. At SanofyvisionIndia Pharma Relations, we do not trust translation agencies alone. Every translated paragraph passes through our internal substantive proofreading. We look at it through the eyes of an official looking for inconsistencies. If the description of the manufacturing method in Polish sounds different than in the original because the translator wanted it to 'sound better', it's a direct road to failure.
Heads-up: Pay special attention to the naming of excipients. Using trade names instead of names compliant with the European Pharmacopoeia is an error that appears in 26% of rejected applications. Documentation must be dry, technical, and compliant with official nomenclature. There is no room here for literary invention. Since September 2016, we have corrected over 1,240 incorrect ingredient names in documentations that came to us for an 'emergency' audit after the first office refusal.
Certificate validity dates
Drug registration is a race against time. It happens that the manufacturer's GMP (Good Manufacturing Practice) certificate expires during the procedure at the Ministry of Health. If you send a document that expires in 14 days, the official will reject the application almost immediately to avoid taking responsibility for monitoring the new version. We have seen this dozens of times. At SanofyvisionIndia Pharma Relations, we use a simple warning system that reminds of approaching deadlines 45 days before the limit date. This allows for smooth submission of new documentation before the office even asks for it.
In 2024, thanks to this approach, we avoided 19 potential rejections for our regular clients. The offices know us and know that our documents are always up to date. Clear rules of the game are fundamental. If you know that an audit at your active substance (API) supplier is delayed, inform the office earlier instead of waiting for a call. Proactivity shortens the waiting time for a decision by an average of 3.2 weeks. Concrete deadlines are something officials look for in your cover letter.
Sometimes the problem is the lack of a current CEP certificate. In one case from May 2024, a client attached a version of the certificate from 2 years ago, claiming that 'after all, the process hasn't changed'. The office had no mercy. The procedure was suspended until the current document from EDQM was delivered. It cost the company the loss of an entire sales season. In our work, we immediately point out such deficiencies without unnecessary paperwork before the application even leaves the client's office. The effectiveness of our actions since 2016 is 97.3% at first submission.
An official will reject an application with an expiring GMP certificate for their own safety. You must be 45 days ahead of the deadline.
Errors in Module 1 – administration kills projects
You often focus on complicated chemistry in Module 3 and trip over simple forms in Module 1. An incorrect manufacturer Tax ID, an illegible signature of an authorized person, or the lack of an original power of attorney – these are reasons why 14.6% of applications land in the bin in the first week. At SanofyvisionIndia Pharma Relations, we have a checklist that counts 87 control points for the administrative part alone. This seems like an exaggeration until it saves your project from being sent back to the start.
Remember that since 2016, offices have largely moved to electronic systems, but requirements for the form of paper documents are still rigorous in some types of procedures. Poor folder arrangement or lack of clear dividers between sections is a lack of respect for the official's time. And an official is also a person. If they get a dossier that is well-arranged, has clear tables of contents, and no typos, they look at it more favorably. This shortens the document checking time by an average of 2h 14min at every stage of formal verification.
No unnecessary paperwork, no beating around the bush – if your Module 1 is not perfect, don't send it. We at SanofyvisionIndia Pharma Relations even check the legibility of stamps. In June 2024, we rejected our own client's application for correction because the director's signature on one of the pages was cut off by the scanner. The client was angry for 5 minutes but thanked us a month later when his competition got a call for supplements and he was already enjoying the start of substantive evaluation.
