Specifically, the new resolution clarifies that the requirement to include the statement “Subject to Control of Narcotics/Psychotropics” and the five-pointed star (red or green, depending on the type of product) must be applied mandatorily to secondary packaging. However, these graphic elements may also be included on primary packaging when its design allows it.

These changes aim to ensure proper interpretation of the graphic requirements established in Article 19 of the relevant regulations, thereby aligning the Guideline with current legislation. This clarification is particularly important for stakeholders in the pharmaceutical industry, as it avoids ambiguous interpretations regarding the type of packaging to which these requirements apply.

You can access the full document at the following link.

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This mechanism will allow products approved by at least two high-surveillance regulatory agencies (such as the FDA, EMA, MHRA, among others) to undergo a faster evaluation process in Chile, avoiding duplicate reviews and optimizing registration times.

The new procedure aims to enhance regulatory efficiency, reduce bureaucratic barriers, and facilitate access to biological medicines in the Chilean market.

You can find the complete document at the following link.

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The ISP has granted a period of 2 years from the date of publication of the resolution for the implementation of these guidelines, without requiring holders to request a labeling modification in the sanitary registration.

You can find the complete document at the following link.

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In the update required by the ISP, the incorporation of safety information regarding the possibility of adverse reactions associated with musculoskeletal and connective tissue disorders, such as jaw osteonecrosis, external auditory canal osteonecrosis, and multiple vertebral fractures following treatment discontinuation, is established.

The deadline for incorporating this information into the “Warnings and Precautions” section of the information leaflets is no more than 90 business days from the date of publication of the resolution.

You can find the complete document of Resolution No. 5855 at the following link.

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The context for the suspension of this service is framed within the opinion No. E272988 of the General Comptroller of the Republic, in which the oversight entity states that, according to article 101 of Supreme Decree No. 3/10, products intended for export are exempt from general requirements related to packaging, information, and labeling, and that export registration requests must evaluate all aspects of quality, safety, and efficacy of the drug, without restricting to a limited examination of aspects.

Given the above, products seeking registration for the sole purpose of export must therefore undergo an ordinary or simplified registration procedure, the latter procedure being valid only “…when dealing with a product manufactured in the country for the exclusive purpose of being exported, which, according to Chilean regulations, is considered a pharmaceutical product and can demonstrate that it is considered a food product in the destination country, the submission of information related to safety and efficacy may be omitted…” as indicated in article 52, No. 4, of Decree No. 3/10.

You can find Decree No. 1932 at the following link.

You can find the Comptroller’s opinion at the following link.

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In this document, the Chilean health authority provides the guidelines regarding the background information required for allergenic products in order to facilitate the correct presentation, ensuring that applicants provide complete and updated information on these products, taking into account the provisions in article 10 of Supreme Decree No. 3 in which it classifies pharmaceutical specialties according to their nature, specifically within biological products, in letter g) of article 12 where allergens are indicated as: “a biological product, intended to identify or elicit a specific and acquired modification of the immune response to an allergizing agent.”

According to the nature of these products, the authority points out that the application must be entered through the ordinary procedure since this is the correct one for biological products.

You can review the complete guide by clicking here.

Source: www.ispch.cl

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Initially, Resolution No. 2198/2022 established that oral contraceptives consisting of active tablets and placebos must be made up of easily distinguishable units by visual and technological means, in terms of color and shape. In the same document, obligations and deadlines were established in relation to the updating of labels and patient information leaflet.

Resolution No. 5250 of November 30, 2022 aims to inform holders of the way in which they must request and process the obligations for oral contraceptives, as follows:

1. The obligation to update labels that detail the color and quantity of active tablets and placebos must be carried out through the respective modification of the sanitary registry (provision 4111010).

2. The update to the patient information leaflet, including the warning mandated by resolution No. 2198/2022, must be carried out through the respective modification of the health registry (provision 411011).

3. A term is granted until March 31, 2023 for the producto license holders subject to resolution No. 2198/2022 to make the modifications described above.

4. The institute will resolve the applications within a period not exceeding 3 months from the submission of the application.

5. Finally, modifications to oral contraceptives that are requested exclusively to comply with resolution No. 2198/2022 will have a zero-cost fee.

Source: www.ispch.cl

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On July 26, 2022, the ISP has issued the exempt resolution No. 3292 that modifies resolution No. 395, incorporating a term of 1 year from the date on which the respective renewal of the sanitary registration is granted to implement the update. of the graphic labeling regarding the condition of sale authorized by the authority. Avoiding incorporating legends that allude to the type of establishment that can market the products, such as “sale in type A establishments”.

Although the update of the labeling will be required by means of the respective health registration renewal resolution, the foregoing does not exclude the possibility that the owner himself, at his own expense and initiative, request the modifications to the labeling without having to wait for the process of renewal of the East.

Source: www.ispch.cl

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The holders have a period of 30 business days from the publication in the official gazette to submit the proposal to the ISP.

ISP will rule on the proposal submitted by the marketing authorization holder, establishing the requirement to submit the modification in the sanitary registration, if it deems it necessary.

Additionally, it is established that the patient information leaflet must contain the following warning: “This product is a contraceptive, and its effectiveness depends on its correct use. Before you start using it, check that the product corresponds to the one prescribed by your doctor or midwife and that the contents of the blister coincide with what is detailed on the package label. In case of doubt, ask to the pharmacist.”

Source: www.diariooficial.cl

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