How to avoid the 3 most common mistakes in a MoH application

PDF format is not just a file extension

Officials at the Ministry of Health work on specific document archiving systems that require the PDF/A standard. If you send an ordinary scan made with an office printer without an OCR text layer, the application may be rejected without reading the substantive content. The document must be searchable, which means the official must be able to copy the drug batch number or the name of the active substance from it into the internal register. In 2023, as many as 47 applications that came to us as 'problematic' only required correct technical formatting.

At SanofyvisionIndia Pharma Relations, we apply the rule 'lack of readability means no decision'. Every attachment longer than 14 pages must have an interactive table of contents. Without this, the person checking the documentation loses time scrolling through the file, which naturally extends the evaluation process by another 12-16 business days. Clear rules of the game require that technology helps rather than hinders communication with the department. We check every byte of data before it reaches MoH servers because we know that correcting a file once submitted takes an average of 3.2 hours of administrative work alone.

File size is also important. Ministerial systems often reject data packets exceeding 23 MB in a single message or transfer. Instead of dividing the application into 10 separate e-mails, which creates chaos in case numbering, appropriate compression that maintains medical standards should be used. Since September 2016, we have handled 217 such mailings and have never had a problem with data integrity. Concrete deadlines require concrete technical preparation, which many manufacturers forget in the heat of the battle for the market.

A simple scan without an OCR text layer is the shortest way for your application to lie at the bottom of a digital drawer for a quarter.

The trap of foreign certificate validity

The most common substantive error we encounter is attaching GMP (Good Manufacturing Practice) certificates whose validity ends during the procedure. According to the act, the document must be valid on the day the decision is issued, not just on the day the application is signed. If your certificate expires in 58 days, and the average processing time in a given category is 120 days, you are guaranteed a call to supplement deficiencies. This interrupts the course of the deadline and resets the official's timer.

At SanofyvisionIndia Pharma Relations, we monitor deadlines 4 months in advance. If we see that documentation from India or another country outside the UE has a short validity period, we suggest refreshing the papers before sending them to Warsaw. It's simple math: better to spend 11 days obtaining a new document now than to wait 3 months for an official letter requesting a correction. Our statistics show that this approach shortens the process by 27% compared to companies acting on their own.

To avoid problems, address data on certificates should also be verified. It often happens that the manufacturer's name on the drug box differs by one comma from the name on the analytical certificate. For an official, these are two different entities. Since September 2016, we have caught 84 such discrepancies, which otherwise would have ended in the rejection of the application. Without unnecessary paperwork and without unnecessary delay – we simply check every letter twice.

Errors in sworn translations

Many companies outsource translations to offices that do not know the pharmaceutical specifics. The result? A sworn translator translates technical terms literally, which makes the description of the production process illogical for an expert from the MoH. For example, an incorrect translation of the substance release methodology results in control questions in 94.6% of cases. The offices know us and know that the documentation prepared by SanofyvisionIndia Pharma Relations is consistent in terms of Polish Pharmaceutical Law terminology.

Heads-up: Remember that every translated document must be permanently linked to the original or its certified copy. We often receive loose translation pages from clients, which in the light of the law are worthless to the MoH. Documentation must be 'unassailable'. In 2024, we saved 14 projects where it was enough to correct only the stamps on the translations for the process to move forward after 4 months of standstill.

At SanofyvisionIndia, we focus on clear rules of the game. If a translation is weak, we say it straight. We do not forward materials that may harm the manufacturer's reputation. The cost of re-translating 20 pages is ridiculously low compared to the losses resulting from delaying a drug's pharmacy premiere by half a year. Our clients' average profit from faster market entry is approximately 2,340 PLN per day per product.

An incorrect technical translation is not just a language issue; it is an error that undermines the credibility of your drug's entire research process.

Lack of consistency between SmPC and leaflet

The Summary of Product Characteristics (SmPC) and the patient leaflet must be a mirror image in terms of dosage and contraindications. It sounds trivial, but in 23 out of 100 applications, we find differences in units of measurement or the age of patients for whom the drug is intended. Such errors are treated as a threat to public health. SanofyvisionIndia Pharma Relations performs a cross-audit of these documents in 47 minutes, eliminating the risk of rejection at the start.

Cooperation with the Ministry of Health requires precision to the milligram. If the SmPC states a concentration of 5 mg/ml and the leaflet says 0.5%, then even if mathematically the same, the official will demand a unification of the record. Every such inquiry (so-called deficiency letter) is a loss of about 19 business days for the circulation of correspondence. Since September 2016, we have learned that it's better to be overzealous in checking commas than to wait for a letter from the office.

According to the act, every change in documentation after its submission requires an additional stamp duty if it does not result from an office call. Our goal is to submit an ideal application the first time. In 2024, we delivered 97 documentation installations to the MoH and only 2 of them required minor corrections, which we handled by phone in 2h 14min. This is precisely what concrete deadlines mean in our work.

How does SanofyvisionIndia shorten the path to MoH?

Our method is based on eliminating information noise. We do not send everything we have to the office, but exactly what the procedure requires. Since September 2016, at 24 Mickiewicza St in Poznań, we have built a knowledge base on how staffing requirements change in registration departments. We know who values meticulousness and who pays attention to bibliography formatting. This isn't magic; it's 11 years of practice in the pharma industry.

On average, our team of 14 people in 2 offices closes processes 43 days faster than the internal departments of large concerns that drown in corporate procedures. With us, the decision-making process takes 15 minutes, not 2 weeks. If the director's signature from India is missing in the documentation, we call him directly instead of writing 5 reports on obstacles. We act concretely because we know that time is money, especially with expiring patents.

We have served 423 clients since 2018, and each of them appreciated that we don't use industry jargon. We say what's wrong, how much repair costs, and when the application will reach the official's desk. Our headquarters in Poznań is open Monday to Friday from 8:00 AM to 4:00 PM (with a coffee break 11:00–11:20 AM), and we respond to emails in 47 minutes on average. No unnecessary paperwork, no empty promises.

We shorten the process by 43 days compared to corporate registration departments because we eliminate 99.7% of formal errors before submission.