New OTC labeling regulations

New OTC labeling regulation – Disposition 753/2012 – February 2012

After a consumer study that revealed that patients had problems interpreting and understanding the information included in OTC drugs patient information leaflets, and the variety of content and format that these leaflets showed across brands and products, a new regulation has been created to standardize the information to the patient and present it in a way that would be easy to understand for everyone.

These new regulations and guidelines have to be implemented within a period of two years for all registered products, and immediately for new registration, variation and change of marketing condition cases.

General points:

Information must be written in Spanish
Information must be clear and accesible
Font size and style must be easily readable
Pictograms, colors, and other visual aids might be included to ensure a correct use of the drug product
Consultation with doctor and/or pharmacist must be encouraged

Specific points: the information must be presented, both on the leaflet and the packaging labeling texts, in a question-and-answer format. Only information relevant to the patient should be included, in layman’s terms.

In the patient information leaflet:

Brand name
Generic name
Pharmaceutical form
Marketing condition: OTC
Made in…
READ CAREFULLY THIS INFORMATION BEFORE USING THIS DRUG PRODUCT
WHAT DOES (comercial name) CONTAIN? Quantity of API, per dosage unit or percentual. Qualitative list of excipients.
ACTION/S
WHAT IS (comercial name) USED FOR? Symptoms and uses.
WHO CAN’T USE THIS DRUG PRODUCT? Include allergies, contraindications and other situations in which use of the product could be adverse.
WHAT PRECAUTIONS SHOUD I TAKE BEFORE USING THIS DRUG PRODUCT? Include warnings and precautions, relevant current and past medical conditions. Include: if you are taking other medication, you are pregnant or breast-feeding, ask your doctor before using this product.
WHAT PRECAUTIONS SHOULD I TAKE WHILE USING THIS DRUG PRODUCT? Include adverse reactions and interactions. Indicate visit to the doctor in the case symptoms get worse or not revert after certain time.
HOW SHOULD I USE (comercial name)? Include dosage regime and administration method, period of treatment, what to do if a dose is omitted, dosage in children, maximum daily dose, detailed explanations on how to use the product, (may include graphic aids) special observations. (take with meals, etc.)
PREPARATION INSTRUCTIONS AND STORAGE CONDITIONS
WHAT SHOUD I DO IN CASE OF OVERDOSE, OR IF I TOOK MORE OF THE PRODUCT THAN NECESSARY? Call and intoxication center, or go to the closest medical care center. Include telephone numbers.
DO YOU HAVE ANY QUESTIONS? Include “ANMAT Answers” number, and company customer care telephone number.
KEEP OUT OF THE REACH OF CHILDREN
AT ANY QUESTION CONTACT YOUR DOCTOR OR PHARMACIST
Storage condition
Made in…
Technical Director:
Drug Product Authorized by the Ministry of Health
Certificate Number
Date of last authorized labeling text:
Presentations:

In the packaging labeling text:

Brand name
Generic name – dose/concentration
Pharmaceutical form
WHAT DOES (comercial name) CONTAIN? Quantity of API, per dosage unit or percentual. Qualitative list of excipients.
ACTION/S
WHAT IS (comercial name) USED FOR? Symptoms and uses
HOW SHOULD I USE (comercial name)? Include dosage regime and administration method, period of treatment, what to do if a dose is omitted, dosage in children, maximum daily dose, detailed explanations on how to use the product, (may include graphic aids) special observations. (take with meals, etc.)
DON’T USE THIS DRUG PRODUCT IF YOU…
The marketed condition (over the counter) should be remarked. (bold font)

Last update: October 2013