Traditional Medicines and OTC Products
A brief overview of the situation regarding traditional medicines and OTC products in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative
medicines and devices?
The requirements for traditional, herbal, complementary, or alternative medicines and devices that have therapeutically property are the same as for drugs. Please see Question 1 of Chapter 3: Marketing, Manufacturing, Packaging and Labeling Advertising.
Only Traditional, herbal, complementary, or alternative “indigenous medicines and devices products” are ruled through special Law No. 17 of June 27, 2016.
If the products don’t have therapeutic properties will be considered food with different regulatory requirements and different Government Offices.
Good manufacturing practices for natural medic products for human use was approved by Resolution No. 58 of September 9, 2020.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
The advertisement for these products requires previous approval by the Publicity and Propaganda Commission of The Ministry of Health.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
There are no specific required claims for traditional, herbal, complementary, or alternative products. However, it is forbidden to advertise properties or characteristics that are not object of the market authorization for the product. All claims must be proven with documental evidence.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
To be classified as OTC over-the-counter (non-prescription) medications, the product must meet the following characteristics:
- Preferably constitute by one active principle or by a long recognized therapeutically effect.
- Possess a wide therapeutic range, proven effectiveness and minimal adverse effects or small clinical urgency.
- Dosage range must be effective, safe and adaptable regarding patient age and weight.
- Must have indication of a medical diagnosis not required and be known for not least of five years.
- Must be aimed to treat symptoms and signs as: mild, common, short duration, widely known and easily identifiable.
- Must be oral administration or topical administration through the skin or mucus membranes, in which the absorption must be minimal. It is not allowed for products to be administered for any parenteral way.
- Must comply with a minimal, effective and safe concentration, without requiring any medical supervision.
- It must not develop tachyphylaxis, dependency or hide more serious diseases.
- The high accidental or intentional dosages must not represent a high or imminent danger for the patient health.
- That the active ingredient or associations have been in the national or international market and preferably be considered as common sold without medical prescription in other countries, with a proven safety for more than five (5) years.
- Must not have the caption “sold under medical prescription” or any other similar phrase.
5. Are there any limitations on locations or channels through which OTC products may be sold?
OTC medicines can be sold at any authorized pharmaceutical and non-pharmaceutical establishment. OTC products must be presented in one-dose containers that have written all the information required for these products or, sell the complete container in integral form (not for individual sale).
6. What health, advertising, and marketing claims may be made for OTC products?
OTC products must have the following claims:
- If you are pregnant or in breastfeeding period, please consult with your doctor before consuming the product.
- If an overdose occurs, please immediately contact a doctor.
- Not for use of children under____.
- If the symptoms persist with the use, reappear or get worse please stop the use and contact a doctor.
- Do not exceed the recommended dosage.
- The Ministry of Health can recommend more claims according to the product.
- Usage and dosage instructions must be clear, specific and in an understandable language for the public.
- The maximum dose administered in 24 hours and the time period for treatment.
- Warnings, contraindications, adverse reactions and interactions. If the product is for pediatric use, must include: “this medication produces a tem-poral relief. If there is no improvement in 48 hours, please contact a doctor”.
- Storage conditions.
- Other texts that the Pharmaceutical and Drug Department considers applicable.
7. Can OTC products be marketed or advertised directly to the public?
Yes, previous approval from the Advertising Commission from the Ministry of Health.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
Filing before the Drug and Pharmaceutical Department a petition for modification of the condition of the sanitary registration.
9. What are the requirements for the importation of either traditional medicines or OTC products?
Please see Question 3 of Chapter 1.