PCP_DR: AEMPS moves personal care filings online

• On 15 September 2026 AEMPS published note BCP 07/2026 and opened PCP_DR, an application for filing the responsible declaration of manufacturing and import activities for personal care products. Until that day the filing was a 2019 Word form, signed and stamped.
• It is not a new rule and not an ingredient restriction. It digitises an obligation that the Medicines Guarantees Act already sets (third additional provision of the 2015 consolidated text) and that AEMPS had been processing on paper.
• It only touches a category that exists solely in Spain: toothpastes outside the cosmetic scope, tattoo inks, head-lice products, intimate, nasal or eye hygiene products. Cosmetics do not move.
• What AEMPS has not written: what happens to companies that already filed their declaration on paper. Neither the note, nor the FAQ, nor the manual says.

Quotations from AEMPS documents and Spanish legislation are our own translation; the links point to the Spanish originals.

1. What exactly changed

The channel changed, not the obligation. Anyone who manufactures or imports personal care products in Spain must file a responsible declaration with AEMPS before starting. The third additional provision of Royal Legislative Decree 1/2015, the consolidated Medicines Guarantees Act, says it: manufacturing and import activities "for cosmetics and personal care products are subject to the responsible declaration regime", filed with AEMPS, which allows the activity to start without prejudice to later verification.

Until now that declaration was a Word document. AEMPS published three templates (manufacturer, importer, both) and a PDF of filling instructions, version 1, October 2019. The template ends with "signature of the holder of the activity/legal representative and company stamp". A company stamp, in 2026.

The information note BCP 07/2026 announces the replacement of that circuit by an application: PCP_DR, accessed through Cl@ve (digital certificate or Cl@ve Permanente). It comes with a manual (version 00, same date) and a questions and answers page with 23 questions, also published on 15 September.

The manual states the purpose in its introduction: to bring filing, verification and inspection into a single application, "eliminating the manual processes of submissions and procedures". It is the same logic AEMPS applied to cosmetics with COSMET2_DR; personal care products were the part of the system still running by hand.

2. Why this only happens in Spain

Worth pausing here, because the category confuses anyone arriving from another EU country.

Article 2.m of RDL 1/2015 defines personal care products (productos de cuidado personal) as substances or mixtures that, without being medicines, medical devices, cosmetics or biocides, are applied to the skin, teeth or mucous membranes for hygiene or aesthetic purposes, or to eliminate ectoparasites. It is a national category. It has no equivalent in Regulation (EC) 1223/2009 and the European Commission does not recognise it.

The AEMPS FAQ lists what falls inside:

The regime differs from cosmetics on two levels. The product needs a prior marketing authorisation from AEMPS under the second additional provision of Royal Decree 1599/1997, which remains in force for this category; it is handled in the BPCP application, with its own fees. And the company that manufactures or imports it files the responsible declaration of activities. PCP_DR deals only with this second layer.

For a cosmetic, by contrast, there is no product authorisation: it is notified in the CPNP, and the company declares its activity in COSMET2_DR. That procedure does not change. We cover it in detail in our guide to AEMPS and cosmetics.

3. Who must file and who need not

According to the FAQ, the declaration must be filed by natural or legal persons who materially carry out the manufacturing, packing, filling or labelling of personal care products in Spain, and those who import them from countries outside the European Union.

The word "materially" does the work. Left out:

• companies subcontracted only for storage or control;
• pharmacies that make these products for sale in their own premises;
• brand owners who outsource the entire production (manufacturing, packing, filling and labelling), even if they own the brand and are responsible for placing the product on the market.

That last point matters: the brand owner who outsources everything does not declare. The manufacturer does. The brand's responsibility for the authorised product remains, through the other route, the second additional provision of RD 1599/1997.

The declaration is filed before the activity starts and enables it from that same day. AEMPS puts it this way: whoever has filed it "may start the manufacturing and/or import activities for personal care products from the date of filing, without prejudice to the verification and checking powers attributed to AEMPS". There is no decision to wait for; this is the mechanism of Article 69 of Law 39/2015.

4. How the procedure works now

What follows comes from the manual and the FAQ.

Access. Only the holder of the activity or their legal representative can file, consult or amend the declaration. If a representative signs, the document proving the representation must be uploaded to the application. The responsible technician can log in, but only to upload documents when AEMPS asks for them.

Filing. The application generates a document with the declared data and a locator code in the signature footer, verifiable at the electronic office. The declaration "shall be deemed filed" once that document with its locator exists, and the filing date is the one on it. This is a substantive change from the Word form: the date is no longer set by the company.

Fee. During filing the application generates a payment code. According to the AEMPS fee table (updated 28 June 2023), verification of a manufacturing declaration (fee 5.05) costs EUR 932.46 and of an import declaration (5.06) EUR 466.23. If both activities are declared, only the manufacturing fee is paid.

Verification. AEMPS first checks that all the data is there; if something is missing, the company gets ten working days to correct it. It can then request documentation on premises, procedures, records and controls, with fifteen working days to upload it. And if it decides to inspect, it notifies the inspection fee (5.09 for manufacturers, EUR 837.18; 5.10 for importers, EUR 418.59) with ten working days to pay. The inspection is carried out by the pharmaceutical inspectorate and its report goes back to AEMPS.

Responsible technician. The company needs one with "adequate qualification". AEMPS specifies that a university degree related to the activities is enough, and that suitability is checked during verification.

Changes. Any change in the declared data or in the activity requires a new declaration. Substantial changes (relocation, new plants or expansion, new presentation forms) carry a fee; a dozen minor changes (company name, address, responsible technician, product categories, subcontracting) are notified without a fee. Total cessation is also notified from the application.

One detail still in the general registry. Changing the person who signs the declaration is not done in PCP_DR: a request must be sent to the Medical Devices Department through the electronic registry of the General State Administration, with the tax ID and the document proving the new ownership or representation.

5. What AEMPS has not said

There is one question any already-declared company asks and that is not among the 23 on the page: do I have to file my declaration again in PCP_DR?

Neither the note, nor the FAQ, nor the manual mentions the declarations filed with the Word form between 2019 and 2026. The manual has a section for companies "registered in the application without a current declaration", but it refers to those that ceased activity or whose declaration was rendered void, not to those that declared on paper. The trade press that covered the news does not clarify it either.

There is an indirect clue. The FAQ of BPCP, the product authorisation application, has said since 2023 that responsible declarations "will continue to be filed through the same channel as before". That channel is now PCP_DR. And the PCP_DR page itself sets that, from its launch, a declaration is only deemed filed when the application generates the document with a locator. The reasonable reading is that the Word form no longer counts for new declarations. On the old ones, the only route is to ask: the address for application issues is cosmetinstal@aemps.es.

Until AEMPS writes it down, any statement about migration is an interpretation, and we would rather not pass it off as a fact.

6. What this has to do with a cosmetics manufacturer

Strictly, nothing. If your whole catalogue is cosmetic, PCP_DR does not affect you and there is nothing to do.

In practice, the line between cosmetic and personal care product runs through some catalogues. A toothpaste with more fluoride than Annex III allows stops being a cosmetic; a tooth whitener outside the hydrogen peroxide limits, likewise; a tattoo ink or a head-lice product are, in Spain, personal care products even if another Member State sells them as a biocide or a medical device. And the consequence is concrete: for those products, CPNP notification is not enough. The product needs authorisation and, if it is manufactured or imported here, the company needs this declaration.

Anyone with references on that border (oral care, tattoo, head lice, intimate hygiene) now has a reason to check which category each one falls into in Spain. That has not changed with PCP_DR; what has changed is that the company filing finally has a filing date that does not depend on a stamp.

7. Sources

• Information note BCP 07/2026 — new PCP_DR application, AEMPS, 15 September 2026
• Questions and answers on the responsible declaration for personal care products, AEMPS, 15 September 2026
• PCP_DR manual for natural and legal persons, version 00, 15 September 2026
• PCP_DR application
• Instructions for filling in the responsible declaration for personal care products, version 1, October 2019 — the previous circuit
• BPCP application FAQ, AEMPS, 4 December 2023
• Marketing authorisation of personal care products, AEMPS
• COSMET2_DR procedure, AEMPS electronic office
• AEMPS fee table, updated 28 June 2023
• Royal Legislative Decree 1/2015 — Art. 2.m and third additional provision
• Royal Decree 1599/1997 — second additional provision and Chapter VII
• Law 39/2015 — Article 69

8. Frequently asked questions

Is PCP_DR for cosmetics? No. Cosmetics use COSMET2_DR. PCP_DR is only for personal care products.

And for authorising a personal care product? No, either. Product authorisation goes through BPCP. PCP_DR is the company declaration.

My brand outsources all manufacturing. Do I declare? No, according to the AEMPS FAQ: the material manufacturer declares. The brand remains responsible for the product being authorised.

How long does AEMPS take to reply? There is no decision. The declaration enables the activity from filing; verification comes afterwards and may include a request for documents (fifteen working days to provide them) and an inspection.

I already filed my declaration in Word. Do I have to repeat it? AEMPS has not published this. See section 5.

9. In short

A category that exists only in Spain had its company filing in a stamped Word form, with instructions last updated in October 2019. Since 15 September 2026 that filing lives in PCP_DR, with a locator code, deadlines counted in working days and the fee generated by the application. The obligation does not change, the amounts do not change, and cosmetics are untouched. What is missing is a line on the old declarations, and until AEMPS writes it, it is best treated as what it is: an open question.

Disclaimer. This article is for information only and does not constitute regulatory or legal advice. It describes what AEMPS published on 15 September 2026 and what we verified in its documents on 17 September 2026; the fees are those of the June 2023 table and may be updated. For compliance decisions, consult the official texts linked above and, in case of doubt, AEMPS itself.