A certificate on its own is rarely enough
Pharmacy buyers ask for the file behind the certificate — the declaration of conformity, the technical file, and the identification data that matches the SKU sitting on the shelf.
PHARMACY & DRUGSTORE
Nasal Strips for Pharmacy and Drugstore Chains
This is the strictest channel we supply. Not because the product is different, but because pharmacy buyers ask for the file behind the certificate, the data behind the pack, and a certificate with each delivery rather than once a year.
What Usually Goes Wrong in Pharmacy Supply
Four failures, none of them about the strip itself.
Identification data has to agree with the pack
UDI-DI and Basic UDI are checked at data level and they have to match what is printed. A mismatch is a listing problem, not a paperwork problem, and it surfaces at the worst moment.
The leaflet has to be in the national language
Instructions for use and the package leaflet are required in the language of the market — per market, not once for Europe. A chain operating in four countries needs four.
A certificate per year is not a certificate per delivery
Pharmacy supply chains ask for a batch certificate with each delivery, and a lot code that still means something when a question is raised eight months later.
What We Do About Each One
All four are documentation and process controls we already run for other chains.
CE marking with the file behind it
Declaration of conformity per SKU and the technical file that supports it, plus our EUDAMED record as manufacturer — which is public, so you can check it yourself rather than take our word for it.
Identification data handled at SKU level
UDI-DI and Basic UDI issued for the models you buy, so the data and the pack agree. The codes we have issued are listed in the resource library rather than quoted second-hand.
Documentation in the language of your market
Instructions for use and the package leaflet produced from our source text into your market language, and versioned with the artwork — so a redesign does not quietly orphan the regulatory file.
A batch certificate with every delivery
Each batch ships with a Certificate of Conformance. Lot codes trace back to the operators who ran the batch, and records are kept for five years.
Your Route
Three ways chains buy from us.
The usual route
Own-brand supply
Your brand and artwork on a specification we already run. From 500 boxes on a stock specification, 5,000 boxes once you want your own printed boxes and display units.
If you want no branding work at all
Wholesale of the stock range
Our stock range at tiered wholesale prices, with consistent reorders and mixed-SKU deliveries. See the wholesale route for how that is priced and shipped.
If you bid into tenders
Tender and medical distribution
Mostly a formatting job: we hold the source documents and complete the dossier in the buyer template. That channel has its own document list in the resource library.
Want to see how the floor actually runs before you commit? Watch the production walkthroughs on the video page, or read how we control a batch. Selling on a marketplace, buying as a distributor, or launching your own brand? Each buyer type has its own route under solutions.
The Pack for Your Channel
Retail channels screen further than the law requires. These lists reflect that.
Pharmacy and drugstore Open the list → Supermarket and retail chains Open the list → Medical distribution and tenders Open the list →
Two of the registrations named there are public and checkable without contacting us: the MHRA entry for Great Britain and our EUDAMED record as manufacturer. Testing reports carry laboratory report numbers we keep out of public circulation, so those are released per enquiry and matched to the market and SKU you are buying.
In Their Words
Published with permission; the quote links to the full note.
We source medical-grade nasal strips for our pharmacy chain across France. HLK's product documentation (MSDS, CoC) is always complete and accurate. Their lead times are reliable even during peak season. Very professional partner.
Tell Us the Country and the Chain
Which market, own-brand or stock range, and roughly what volume per delivery. That is enough for us to tell you which documents apply and what the first order looks like.
Or start with the free sample kit and the EU certification guide.
Pharmacy and Drugstore FAQs
What pharmacy buyers ask before listing an own-brand product.
Can we sell these under our own pharmacy brand?
Yes. Own-brand supply is the usual route for pharmacy and drugstore chains. Your artwork goes on the strip and the pack, the HLK name does not, and the documentation is issued for your SKUs. Stock specifications start at 500 boxes; your own printed boxes and display units start at 5,000 boxes.
Are you registered in EUDAMED?
Yes — HLK is recorded as manufacturer SRN CN-MF-000049679. It is a public record on the European database, not a page on our site, so you can look it up directly. We link it from the resource library rather than asking you to take our word for it.
What is UDI-DI, and do we need it?
UDI-DI identifies a specific device model; Basic UDI-DI groups a family of models and is referenced in the declaration of conformity and in the EUDAMED record. Which of them your chain asks for depends on how it registers products. We issue the codes for the models you buy and list the ones already issued in the resource library, so the data and the pack agree.
Do you send a certificate with each delivery?
Yes. Each batch ships with a Certificate of Conformance. Lot codes trace back to the operators and the shift that ran the batch, and we keep the records for five years, which is what makes a question raised months later answerable.
Who is your EU Authorised Representative?
HUMISS TRADING S.L. in Madrid, SRN ES-AR-000040177. If your market is Great Britain rather than the EU, the equivalent is a UK Responsible Person — ours is Intercert Global Ltd in London — alongside the UKCA declaration and our MHRA registration, reference 38014.
Can you produce the leaflet in our language?
Yes. Instructions for use and the package leaflet are produced from our source text into the language of your market. Tell us the market at enquiry stage so the translation is scheduled with the artwork instead of after it.
Does CE cover Great Britain as well?
No. CE applies in the EU and UKCA applies in Great Britain — England, Scotland and Wales — with Northern Ireland following its own arrangement. Our UKCA declarations are issued per SKU rather than per company, and Class I devices have no notified body and no certificate, only the manufacturer declaration.
More questions? Visit our full FAQ page or contact our team.