Pharmaceutical labels – 5 steps to make them compliant

Pharmaceutical labels_header

Getting a new pharmaceutical product on the market usually takes 10 to 15 years! Yeah, that’s a long time. During this period, companies spend a lot of time ensuring compliance with numerous laws and regulations for pharmaceutical industry products.

And packaging labels are one important piece of the puzzle. They need to be accurate, up to date, and transparent. Plus, when you’re selling multiple products in different markets simultaneously, this quickly becomes an organizational nightmare. 

To make sure your labels are error-free by the time they are sent to the print and in production, you need to set up a bulletproof pharma review process

In this guide, we’ll show you everything you need to deliver accurate and compliant labels – without fearing for patient safety or sending a wrong label to print! 

But first …

What is a pharmaceutical label?

A pharmaceutical label is a printed or written material with essential information about a pharmaceutical product. It needs to give essential information about the drug, including instructions for use, warnings, dosage, and other necessary information to ensure patient safety. 

Health authorities, like the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe, regulate pharmaceutical labels to make sure they deliver accurate information.

Skip to step two to see all the must-have details for your pharmaceutical labels.

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Five steps to make pharmaceutical labels

The process of creating pharmaceutical labels is pretty complex. There are numerous details to cover and a range of stakeholders to include in the process. All while having strict deadlines in mind.

To make sure you overcome all these challenges, you’ll need a solid process and the help of pharmaceutical packaging solutions.

Let’s look at the five steps for clear and compliant pharmaceutical labeling.

1. Understand regulatory requirements

All pharmaceutical and nutraceutical labels must comply with strict regulations set by authorities like the FDA or EMA in Europe. Otherwise, your company can face severe legal and financial troubles.

Here’s what you need to follow:

  • Label content requirements – you have to list active ingredients, dosage form, strength, route of administration, usage instructions, warnings, and expiry date
  • Design specifications – specific font sizes, color contrasts, use of certain symbols, and language requirements
  • Electronic labeling requirements – additional requirements for all digital products

2. Gather accurate and comprehensive information

One thing that every regulatory agency requires is the importance of delivering accurate and comprehensive information to patients for all over-the-counter and prescription drugs. 

Here’s what high-quality pharmaceutical labels need to include:

  • Brand and generic names – the trade name and the active ingredient(s) of the drug
  • Dosage form and strength – information about the form (is it a tablet or a liquid?) and the strength of the medication (for example: 10 mg)
  • Indications – approved uses or conditions that the drug is intended to treat
  • Dosage and administration – recommended doses and how to take the medication
  • Warnings and precautions – important safety information, including potential side effects and interactions with other drugs or medical conditions
  • Contraindications – situations or conditions where the drug should not be used
  • Storage instructions – how to store the medication properly (for example: temperature or light sensitivity)
  • Manufacturer information – name and contact details of the company that produces the drug
  • Expiration date – the date after which the medication shouldn’t be used
  • Lot or batch number – identification number for tracking the production batch
  • Instructions for use – detailed steps on how to use the medication properly

3. Designing the label 

Designing your pharmaceutical packaging and label isn’t just about making it look pretty. It has to contain all the important information, be clear and readable, and use standardized symbols. 

This means that regulatory agencies even dictate details like the color and the size of the font you should use, how to achieve good contrast between colors, and what information to prioritize. Only by strictly following these steps can you create a design that stands out while following all the necessary regulations. 

4. Proofreading and quality control

No label can go to print without a thorough pharmaceutical review process. And to make sure all scientific, regulatory, and other important information for the patient is well communicated, you’ll need to include multiple stakeholders in your workflow.

That’s where a dedicated review and approval tool like Filestage makes a huge difference. Filestage allows you to stop chasing approvals over email by simply inviting all your reviewers to leave feedback on a single platform. 

Plus, you can separate different groups of stakeholders into multiple reviewer groups and make sure there’s never any confusion with different types of feedback. Because, why would your legal team wante to read through all the feedback regarding the exact shade of red you’re going to use for the font?

Once everyone is happy with the design, they can easily hit the approve button and seal the deal. No more confusion, undefined approvals, or missed deadlines! 

Karina Berner
“Filestage saves our company a huge amount of time. Instead of writing detailed instructions over email, reviewers can just click on a file to add comments in context. This makes everything faster – from giving feedback, to managing the process, to making edits before sharing the next version.”

Karina Berner, Creative Production Specialist at Sartorius

Pharma packaging feedback

5. Printing and production

Now that you have the final version of the pharmaceutical label, it’s time to send it to print. When choosing the label material, always choose high-quality materials that can withstand various environmental conditions, such as moisture and temperature changes.

Then, decide on printing methods that ensure high-quality and durable prints. Are you going for digital, flexographic, or something else? Whatever method you choose, make sure it’s suitable for your product.

The final step is quality control measures. Here you need to implement processes to make sure your printed labels match the approved designs and are free from defects. Again, Filestage can help you overcome this step by allowing you to compare different versions of your design.

Final thoughts 

Pharmaceutical labeling is all about complying with marketing regulations and considering the patients’ wellbeing. And with such important objectives in mind, this tiny piece of paper holds a lot of responsibility. That’s why it’s important to establish strict guidelines and processes, and use dedicated tools to help your team catch mistakes on time.

Looking to establish a compliant and efficient review process for pharmaceutical labels? Grab your free Filestage trial today →