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Неофицијален пречистен текст (23 изворни акта, 106/07–267/25)

Закон за лековите и медицинските средства — неофицијален пречистен текст (Law on Medicines and Medical Devices — unofficial consolidated text)
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What this code is

Неофицијален пречистен текст (23 изворни акта, 106/07–267/25) is the official MALMED identifier for “Закон за лековите и медицинските средства — неофицијален пречистен текст (Law on Medicines and Medical Devices — unofficial consolidated text)”. Неофицијален пречистен текст (23 изворни акта, 106/07–267/25) is the official identifier MALMED uses for this instrument.

Instrument
Неофицијален
Full name
Неофицијален пречистен текст (23 изворни акта, 106/07–267/25)
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Registration
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Macedonian
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
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207 articles · 1 language version
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

About this regulation

Закон за лековите и медицинските средства — неофицијален пречистен текст (Law on Medicines and Medical Devices — unofficial consolidated text)

The Law on Medicines and Medical Devices as a consolidated text — MALMED’s own .docx assembly of 23 source acts, from the basic text in „Службен весник на РМ“ бр. 106/07 to „Службен весник на РСМ“ бр. 267/25. The publisher marks it неофицијален (unofficial), and that wording is kept in the record’s title and here rather than being presented as the gazette’s own consolidation; the amended-date field records the last source act, not a date the document states about itself. Chapter IV МЕДИЦИНСКИ СРЕДСТВА is the device part, running from Article 110 to Article 140 in the consolidated text’s own numbering, in ten sub-chapters: IV.1 classification; IV.2 essential, general and particular conditions; IV.3 conformity assessment; IV.4 marking; IV.5 manufacture; IV.6 distribution; IV.7 materiovigilance; IV.8 advertising; IV.9 donations — with the printed numbers IV.5 and IV.6 each used twice, marking and clinical investigation both being labelled IV.5, and distribution and clinical investigation both IV.6. Chapter V НАДЗОР opens at Article 141; the medicines chapters (I to III) are ingested with it because the two are one statute and the device provisions cross-refer to the Agency, the register and the inspection chapters. Structure as ingested: a preamble block; 31 chapter blocks (ch-i to ch-vii with the source’s own decimal sub-chapters — ch-iii-2 to ch-iii-11 and ch-iv-2 to ch-iv-12 — plus ch-vi-а for the later КАЗНЕНИ ОДРЕДБИ); 207 article blocks; and 23 `drugi-zakoni-1` to `drugi-zakoni-23` section blocks carrying the ОДРЕДБИ ОД ДРУГИ ЗАКОНИ appendix, which is where each amending act’s own transitional and final provisions are printed. **Three defects in the source are carried, not repaired.** (1) The chapter numbering repeats: the printed IV.5 and IV.6 each head two different chapters, so the ids take a positional suffix (`ch-iv-7`, `ch-iv-8`) and the printed labels are left as they are. (2) `Член 156-ѓ` is printed twice, so the second copy takes the id `art-156-ѓ-2`. (3) Five articles — Член 142, 142-а, 143, 144 and 145 — are printed as `(Избришан)` with their numbers retained, and the block ids keep those numbers rather than closing the gaps. The consolidated text’s table of contents (`Содржина:`, 33 entries) is **not** ingested: it duplicates the chapter and article headings, and the corpus carries no table-of-contents blocks anywhere, so it is treated as navigational furniture. Ingested from the .docx MALMED serves, reading the paragraphs directly out of `word/document.xml`.

Неофицијален пречистен текст (23 изворни акта, 106/07–267/25) is the official identifier MALMED uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.