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Focus on Regulation

Updates on the newest regulatory legislation (Royal Decree 717/2019) in Spain

On 5 December 2019, the Official State Gazette of Spain published a new regulation passed by the Spanish government which has introduced many significant developments in the Spanish legal framework on medicinal products for human use, such as new obligations on marketing authorisation holders, further requirements on safety features for medicinal products, or the deletion of the Spanish category of “medicinal product under special medical monitoring”, among other important developments. This new piece of legislation is Royal Decree 717/2019, of 5 December 2019, amending Royal Decree 1345/2007, of 11 October 2007, on the authorisation procedure, registration and dispensing conditions for industrially manufactured medicinal products for human use.

Below we highlight five of the main developments introduced by RD 717/2019:

1. New obligations on MAHs

RD 717/2019 has introduced certain new obligations on marketing authorisation holders (“MAHs“) and has modified other preexisting obligations. The most relevant developments related to MAHs’ obligations are:

a) MAHs shall keep the marketing status of their medicinal products updated in the Spanish Register of Medicinal Products (Registro de Medicamentos).

b) MHAs shall inform the Spanish National Agency for Medicinal Products and Medical Devices (“AEMPS“) of any unexpected restrictions on the supply of any medicinal product as soon as they are detected. In the event that the supply shortage of a particular medicinal product has an impact on healthcare needs, MAHs shall collaborate with the AEMPS in the implementation of the necessary measures to address the need.

c) MAHs shall notify the suspension of the marketing of any medicinal product with, at least, a six-month prior notice (note that before the term was two months).

2. New regulation on the safety features developed by Commission Delegated Regulation (EU) 2016/161

RD 717/2019 has specified, at a national level, certain aspects that the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 (“Commission Delegated Regulation (EU) 2016/161“), which complemented Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, left to the will of the Member States.

Some of these Spain-specific developments are:

a) Extension of the obligation to include the safety features:

In relation to the possibility for Member States to extend the scope of application of the safety features provided for in Section 2(1)(c) of Delegated Regulation (EU) 2016/161, RD 717/2019 establishes that it can be done by a decision of the Ministry of Health, Consumption and Social Welfare. In particular, RD 717/2019 provides for that the scope of the application of the unique identifier may be extended for reasons of pharmacovigilance for medicinal products subject to prescription and for reimbursement purposes for those medicinal products dispensed under the National Health System; and that the scope of the obligation to include an anti-tampering device may be extended to other medicinal products in order to strengthen the guarantees of patient safety.

b) Additional verifications of the safety features:

RD 717/2019 also foresees the possibility of requiring wholesalers to carry out additional verifications of the safety features to those foreseen in art. 20 of the Delegated Regulation (EU) 2016/161. These additional verification obligations would only be triggered if the AEMPS requires it by means of a decision grounded on a potential health risk.

In addition, in accordance with Section 23 of Delegate Regulation (EU) 2016/161, RD 717/2019 requires that wholesalers or the MAH, where applicable, verify the authenticity and integrity of the safety features and decommission the unique identifier of the medicinal products when (i) they are sold directly to HCP, dental practitioners, veterinaries and podiatrists; (ii) they are intended for public health programs developed by health authorities; (iii) they are supplied to Ministry of Defense’s storage and distribution centers for public health programs within the framework of missions; and (iv) they are supplied to the sponsor of a clinical trial.

c) National repositories:

RD 717/2019 regulates certain aspects relating to the national repository used to verify the authenticity of unique identifiers. This repository is currently managed by the non-profit limited company called “Sistema Español de Verificación de Medicamentos”. In addition, RD 717/2019 has also created a specific repository for the National Health System (“NHS“), called “Nudo SNSFarma”. This repository will apply to all medicinal products that include a unique identifier and are dispensed at the expense of the NHS. This system will enable regional authorities and other NHS managing bodies send the verification data for medicinal products financed by the NHS and will provide the necessary information on reimbursement.

3. The Spanish packaging “seal” for reimbursement will remain mandatory until, at least, February 2024

RD 717/2019 establishes that the Spanish packaging seal (“cupón precinto”) will coexist with the unique identifier until 9 February 2024 for medicinal products dispensed in pharmacies reimbursed by the NHS. After that date, the packaging seal may only be deleted if the Health Ministry issues a decision specifying what information contained in the packaging seal shall be incorporated in the outer packaging. This decision shall also regulate a new invoice verification procedure populated with the information provided by the abovementioned “Nudo SNSFarma”.

4. The Spanish category of “medicinal products under special medical monitoring” has been deleted

The Spanish category of “medicinal products under special medical monitoring” (i.e. medicinal products intended for outpatients which may cause very serious adverse effects and which require a prescription by certain specialist HCP and special monitoring during treatment), has been deleted. The deletion of this category implies, among other things, that such medicinal products shall no longer bear the “ECM” mark/abbreviation on the packaging (note that ECM stands for “medicinal products under special medical monitoring”). However, RD 717/2019 allows these medicinal products to continue to be marketed until stocks run out without the need to change the labelling. Once stocks are exhausted, these medicinal products shall no longer include the “ECM” mark/abbreviation on their packaging. This packaging change may be done without prior approval. However, the MAH shall mention the deletion of this marking in the first application for any variation affecting the packaging or in the application for the five-yearly renewal of the marketing authorisation, whichever occurs first.

5. Homeopathic products with therapeutic indication shall be evaluated with the same criteria as any other medicinal product

RD 717/2019 establishes that homeopathic products with therapeutic indication shall be evaluated with the same criteria as any other medicinal products (RD 717/2019 has deleted the previous reference to the need to “take into account their homeopathic nature” when evaluating a homeopathic product).

We hope the above was of your interest.

Please let us know if you need us to clarify or to further develop any issue related to this new piece of legislation.