Requirements for drug labeling for its registration in Ukraine
When registering a medicinal product in Ukraine, special attention should be paid to its packaging and labeling, because there are also certain requirements for them.
The labeling text will be checked during one of the expert examinations during registration, and after getting a Registration Certificate, but before importing medicinal products into Ukraine, graphic package layouts must be prepared and submitted for registration to the Unified Automated Information System (UAIS) of the State Service of Ukraine on Medicines and Drugs Control.
When importing medicines, the packaging will also be carefully checked, and the slightest mismatch can lead to trouble — a delay of goods at the border or even the revocation of the certificate.
Understanding of the drug labeling requirements is a key to correct documents and the application for registration in Ukraine.
Today, we will tell you about the basic drug labeling requirements in Ukraine. If you want to be sure that your labeling complies with the law or want to go through the whole registration procedure without any problems — contact our specialists for personal consultation.
What information should be indicated on the package of a medicinal product for its registration in Ukraine?
Any medicinal product subject to registration in Ukraine must have a certain design included in the package: labels on the package, package insert, instructions, etc.
There are general and more specific requirements for the packaging and labeling of medicinal products depending on the type of drug and the type of packaging: primary or secondary.
The packaging of a medicinal product must:
Be adapted to use — for example, if a blister involves a certain number of tablets, they should be packaged in such a way that when one is removed, the rest remain protected from contamination;
Prevent the contents of the package from being opened unobtrusively;
Protect the contents against all adverse external influences;
Contain the required information about the medicine (more on that in a bit);
Provide the optimal amount (by weight, volume), depending on the scheme of application of the drug, product units for sale.
Information that the drug package must have:
the drug name, including the INN (if it is a single-component drug) — if the drug can be used in different dosage forms, for example, syrup and tablets, the form of the drug must be indicated on the package;
the target population (if the drug may be produced for different age groups)
active ingredients of the drug in qualitative and quantitative terms;
dosage form with a mandatory indication of the weight, volume or number of dosage units contained in the package;
a list of excipients, if they have any known effect — in this case, disclosed information about the substance and its effect must be given in the Instructions to the drug, and a note to this effect must be made on the package;
the method of administration, application of the drug;
the date of expiry;
special warnings — for example, about the necessity to store the drug within the safe temperature range, in a place inaccessible to children, etc;
the name and location of the drug manufacturer;
There are separate requirements for the labeling of drugs, depending on their purpose or storage capacity. For example, if the drug is contained in a bottle (primary packaging), it must be labeled with a label that duplicates the separate information of the box (secondary packaging):
the name of the drug;
the period of validity and the expiration date;
the manufacturer’s name;
volume in milliliters, etc.
If a drug belongs to a group of traditional herbal medicines, its packaging must indicate this fact, as well as contain an indication of the need to consult a doctor before taking the drug.
There can be many examples of different labeling and packaging requirements, as well as the types of drugs. Please contact our experts for more information about your medicinal product.
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7 Dido points is a minimum font size requirement for the drug packaging.
The various manufacturer's technological designations and production license numbering, special cautions, must be clearly indicated in the marking text on the package.
Text language on the drug package and Braille
The drug package may contain text in several languages, one of which must be recognized in Ukraine as a language of international communication.
Primary packaging containing small text may contain text in Ukrainian/Russian/English/Latin, or a combination of languages.
There are also requirements for the writing of the drug series number, the indication of the expiration date, etc.
Braille labeling on the primary packaging (blisters, vials, ampoules) is not required, but it must necessarily be applied to the secondary packaging. There are only a few types of drugs that may not have braille labeling — these are mostly drugs that are not widely available and are used by highly specialized professionals with medical education.
Braille labeling must contain information about the name and form of the medicine, as well as the dose of the active ingredient.
If you are not sure whether the package of your medicine meets all requirements of the Ukrainian law — we will examine it and help you to pass all registration stages, including compiling a Dossier of medicinal product.
The cost of drug registration with our company or drawing up registration instructions can be found here.
You can also read our other materials on this topic on the service page if you want to get more useful information about registration of a medicinal product in Ukraine.
Do you need consultation or practical assistance with the drug marketing authorization in Ukraine? Don’t hesitate to contact us! We will prepare all the necessary information for you to successfully register a medicinal product on your own, or we will take care of the whole process.
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